A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00562120
Collaborator
(none)
21
1
4
8
2.6
Study Details
Study Description
Brief Summary
An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Double Dummy, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of An H3 Receptor Antagonist (PF-03654746) On Congestion Following A Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis.
Study Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Aug 1, 2008
Actual Study Completion Date
:
Aug 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: Placebo
A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.
|
| Active Comparator: Allegra
|
Drug: Allegra
A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.
|
| Active Comparator: Allegra-D
|
Drug: Allegra-D
A single oral dose of Allegra-D is dosed to subjects as an active comparator.
|
| Experimental: PF-03654746
|
Drug: PF-03654746
A single oral dose of PF-03654746 is the investigational drug being studied.
|
Outcome Measures
Primary Outcome Measures
- Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry [2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period]
Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Amin proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.
- Nasal Volume Proportion Measured Using Acoustic Rhinometry [2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period]
Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Nasal volume proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.
Secondary Outcome Measures
- Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry [2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period]
Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest 'post-allergen challenge' Amin measurement of the 3 measures.
- Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry [2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period]
Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest 'post-allergen challenge' nasal volume measurement among the 3 measures.
- Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea [2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period]
Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for 'post-diluent, pre-allergen challenge' measure and 'post-challenge' measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.
- Nasal Symptom Scores: Sneezing [2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period]
The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where 'post-diluent, pre-allergen challenge' included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and 'post-allergen challenge' included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.
Other Outcome Measures
- Serum PF-03654746 Concentration [1 hr 30 min post dose on Day 1 of each intervention period]
Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years.
-
Subjects that respond to a ragweed nasal allergen challenge at screening.
Exclusion Criteria:
-
History of asthma or FEV1 < 80% predicted.
-
Significant concomitant disease or medications.
-
Symptoms of allergic rhinitis within 2 weeks prior to screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68131 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00562120
Other Study ID Numbers:
- A8801003
First Posted:
Nov 21, 2007
Last Update Posted:
Apr 16, 2014
Last Verified:
Mar 1, 2014
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D | PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo | Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg | Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|---|---|
| Arm/Group Description | PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period. |
| Period Title: First Intervention Period | ||||
| STARTED | 6 | 5 | 5 | 5 |
| Treated | 5 | 5 | 5 | 5 |
| COMPLETED | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 2 | 0 | 0 | 0 |
| Period Title: First Intervention Period | ||||
| STARTED | 4 | 5 | 5 | 5 |
| COMPLETED | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: First Intervention Period | ||||
| STARTED | 4 | 5 | 5 | 5 |
| COMPLETED | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: First Intervention Period | ||||
| STARTED | 4 | 5 | 5 | 5 |
| COMPLETED | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: First Intervention Period | ||||
| STARTED | 4 | 5 | 5 | 5 |
| COMPLETED | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: First Intervention Period | ||||
| STARTED | 4 | 5 | 5 | 5 |
| COMPLETED | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: First Intervention Period | ||||
| STARTED | 4 | 5 | 5 | 5 |
| COMPLETED | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Entire Study Population |
|---|---|
| Arm/Group Description | All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first). |
| Overall Participants | 20 |
| Age, Customized (participants) [Number] | |
| 18 to 44 years |
15
75%
|
| 45 to 64 years |
5
25%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
60%
|
| Male |
8
40%
|
Outcome Measures
| Title | Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry |
|---|---|
| Description | Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Amin proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract. |
| Time Frame | 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. |
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo |
|---|---|---|---|---|
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. |
| Measure Participants | 20 | 19 | 19 | 19 |
| Mean (Standard Deviation) [ratio] |
0.760
(0.1504)
|
0.742
(0.2552)
|
0.717
(0.1935)
|
0.795
(0.3044)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.302 |
| Comments | P-value was based on one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.134 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.229 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.544 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.710 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.816 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
| Title | Nasal Volume Proportion Measured Using Acoustic Rhinometry |
|---|---|
| Description | Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Nasal volume proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract. |
| Time Frame | 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. |
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo |
|---|---|---|---|---|
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. |
| Measure Participants | 20 | 19 | 19 | 19 |
| Mean (Standard Deviation) [ratio] |
0.800
(0.1825)
|
0.796
(0.2641)
|
0.744
(0.1594)
|
0.856
(0.3859)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.269 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.097 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.252 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.479 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.521 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.952 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
| Title | Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry |
|---|---|
| Description | Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest 'post-allergen challenge' Amin measurement of the 3 measures. |
| Time Frame | 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. |
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo |
|---|---|---|---|---|
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. |
| Measure Participants | 20 | 19 | 19 | 19 |
| Mean (Standard Deviation) [square centimeter (cm^2)] |
0.155
(0.0876)
|
0.157
(0.1159)
|
0.204
(0.0951)
|
0.190
(0.1510)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.130 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.663 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.138 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.124 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.134 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.978 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
| Title | Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry |
|---|---|
| Description | Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest 'post-allergen challenge' nasal volume measurement among the 3 measures. |
| Time Frame | 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. |
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo |
|---|---|---|---|---|
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. |
| Measure Participants | 20 | 19 | 19 | 19 |
| Mean (Standard Deviation) [cubic centimeter (cm^3)] |
3.132
(2.4120)
|
3.244
(2.3676)
|
4.443
(2.9502)
|
3.275
(2.7001)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.357 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.952 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.480 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.043 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.753 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
| Title | Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea |
|---|---|
| Description | Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for 'post-diluent, pre-allergen challenge' measure and 'post-challenge' measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period. |
| Time Frame | 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. |
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo |
|---|---|---|---|---|
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. |
| Measure Participants | 20 | 19 | 19 | 19 |
| Nasal congestion: Pre-allergen challenge |
0.2
(0.36)
|
0.4
(0.42)
|
0.4
(0.57)
|
0.4
(0.59)
|
| Nasal congestion: Post-allergen challenge |
1.5
(1.20)
|
1.8
(1.30)
|
1.9
(1.42)
|
2.2
(1.48)
|
| Nasal congestion: Post-oxymetazoline |
0.8
(1.16)
|
0.8
(1.21)
|
0.9
(0.85)
|
0.9
(1.20)
|
| Nasal Itching: Pre-allergen challenge |
0.0
(0.07)
|
0.1
(0.23)
|
0.0
(0.08)
|
0.1
(0.31)
|
| Nasal Itching: Post-allergen challenge |
0.4
(0.71)
|
0.8
(1.10)
|
0.9
(1.12)
|
1.4
(1.43)
|
| Rhinorrhea: Pre-allergen challenge |
0.1
(0.23)
|
0.1
(0.17)
|
0.2
(0.39)
|
0.1
(0.33)
|
| Rhinorrhea: Post-allergen challenge |
0.6
(1.01)
|
1.1
(1.48)
|
1.3
(1.30)
|
1.9
(1.42)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.127 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.103 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.218 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.905 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.273 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.048 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.496 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.190 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.019 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.061 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.778 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.102 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
| Title | Nasal Symptom Scores: Sneezing |
|---|---|
| Description | The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where 'post-diluent, pre-allergen challenge' included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and 'post-allergen challenge' included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period. |
| Time Frame | 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. |
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo |
|---|---|---|---|---|
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. |
| Measure Participants | 20 | 19 | 19 | 19 |
| Sneezing: Pre-allergen challenge |
0.0
(0.07)
|
0.1
(0.23)
|
0.1
(0.61)
|
0.1
(0.17)
|
| Sneezing: Post-allergen challenge |
0.7
(1.54)
|
0.6
(0.92)
|
1.2
(1.94)
|
3.6
(3.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Placebo |
|---|---|---|
| Comments | An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Allegra-D, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Placebo |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.000 |
| Comments | P-value was based on a one-sided test. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.217 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 1 mg, Allegra-D |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.156 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | PF-03654746 10 mg, PF-03654746 1 mg |
|---|---|---|
| Comments | An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.848 |
| Comments | P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity. | |
| Method | ANOVA | |
| Comments | ||
| Title | Serum PF-03654746 Concentration |
|---|---|
| Description | Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period. |
| Time Frame | 1 hr 30 min post dose on Day 1 of each intervention period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment. |
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg |
|---|---|---|
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. |
| Measure Participants | 20 | 19 |
| Mean (Standard Deviation) [nanogram per milliliter (ng/mL)] |
34.16
(17.85)
|
2.78
(1.55)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively. | |||||||
| Arm/Group Title | PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo | ||||
| Arm/Group Description | PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. | ||||
All Cause Mortality |
||||||||
| PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| PF-03654746 10 mg | PF-03654746 1 mg | Allegra-D | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/20 (25%) | 2/19 (10.5%) | 0/19 (0%) | 2/19 (10.5%) | ||||
| General disorders | ||||||||
| Feeling jittery | 1/20 (5%) | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 0/20 (0%) | 1/19 (5.3%) | 0/19 (0%) | 0/19 (0%) | ||||
| Gastroenteritis | 1/20 (5%) | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) | ||||
| Sinusitis | 0/20 (0%) | 1/19 (5.3%) | 0/19 (0%) | 0/19 (0%) | ||||
| Urinary tract infection | 1/20 (5%) | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) | ||||
| Viral upper respiratory tract infection | 0/20 (0%) | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Anorexia | 1/20 (5%) | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) | ||||
| Psychiatric disorders | ||||||||
| Disorientation | 1/20 (5%) | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) | ||||
| Hallucination | 1/20 (5%) | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) | ||||
| Insomnia | 2/20 (10%) | 1/19 (5.3%) | 0/19 (0%) | 0/19 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00562120
Other Study ID Numbers:
- A8801003
First Posted:
Nov 21, 2007
Last Update Posted:
Apr 16, 2014
Last Verified:
Mar 1, 2014