An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00804687
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 6
• Duration (Months): 3
• Patients Per Site Per Month: 17.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and pseudoephedrine compared to placebo (medication with no active ingredients) in participants with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen, dust or animal hair).

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Other: Placebo; Drug: JNJ-39220675; Drug: Pseudoephedrine	Phase 2

Detailed Description

This is a randomized (the study drug is assigned by chance), single-dose, single-blind (a clinical trial in which the person giving the treatment, but not the participant, knows which treatment the participant is receiving), double-dummy, placebo-controlled, three-treatment period, cross-over (participants may receive different interventions sequentially during the trial) study of JNJ-39220675 in participants with allergic rhinitis. The duration of study will be 20-64 days per participant. The study consists of 2 parts: Screening (that is, 30 days before study commences on Day 1) and Treatment (consists of single-dose of either JNJ-39220675 solution [10 milligram], Pseudoephedrine tablet [60 milligram] or Placebo, in subsequent three-treatment periods, each separated with washout period of 6 days). All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. Participants will be given dose approximately 2 hours before entry into the environmental exposure chamber where they will be exposed to ragweed pollen for 8 hours. Efficacy will primarily be evaluated by measurement of nasal congestion that will be assessed through nasal cavity geometry that is, minimal cross-sectional area of nasal cavity by Acoustic rhinometry. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single-Dose, Single-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-Over Study to Compare the Relative Efficacy of JNJ-39220675, Pseudoephedrine and Placebo for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-39220675 then Pseudoephedrine then Placebo Single-dose of JNJ-39220675 will be administered as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally along with placebo tablet in first treatment period; after that in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 milligram (mg) pseudoephedrine tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.	Other: Placebo; Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Drug: JNJ-39220675; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Drug: Pseudoephedrine; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Experimental: JNJ-39220675 then Placebo then Pseudoephedrine Single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.	Other: Placebo; Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Drug: JNJ-39220675; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Drug: Pseudoephedrine; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Experimental: Placebo then JNJ-39220675 then Pseudoephedrine Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.	Other: Placebo; Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Drug: JNJ-39220675; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Drug: Pseudoephedrine; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Experimental: Placebo then Pseudoephedrine then JNJ-39220675 Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.	Other: Placebo; Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Drug: JNJ-39220675; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Drug: Pseudoephedrine; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Experimental: Pseudoephedrine then JNJ-39220675 then Placebo Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.	Other: Placebo; Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Drug: JNJ-39220675; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Drug: Pseudoephedrine; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Experimental: Pseudoephedrine then Placebo then JNJ-39220675 Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.	Other: Placebo; Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.; Drug: JNJ-39220675; Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.; Drug: Pseudoephedrine; Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Outcome Measures

Primary Outcome Measures

1. Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry [2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period]

   The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.

Secondary Outcome Measures

1. Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS) [2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period]

   The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).

2. Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1 [0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period]

   The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.

3. Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1 [Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period]

   The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants must have a clinical history of seasonal allergic rhinitis with seasonal onset and offset of nasal allergy symptoms at least during each of the last two ragweed allergy seasons

• Participants must have documentation of a positive skin test within 12 months of Screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test (allergy tests performed by injecting allergy-causing substances underneath the skin to see if they cause a reaction) for ragweed allergen

• Female participants must not be pregnant, lactating or be able to become pregnant

• Male participants must consent to use a medically acceptable method of contraception throughout the entire study period and for 3 months after the study is completed

• Participants with body mass index between 18 and 32 kilogram per square meter

Exclusion Criteria:

• Participants with clinically significant physical findings of nasal anatomical deformities

• Participants with a history of risk factors for torsades de pointes (heart failure, hypokalemia, family history of long QT syndrome), use of concomitant medications that prolong the QT or QTc interval or an abnormal 12-lead electrocardiogram except for clinically non-significant bradycardia

• Participants with history of exposure to an investigational treatment within the 30 days before the Screening Visit, or has ever taken JNJ-39220675 previously

• Participants with a history of clinically significant allergies, especially known hypersensitivity or intolerance to any drug or known allergy to the study drug or any of the excipients of the formulation

• Participants with a history of severe respiratory infection or disorder, epilepsy or seizures, coronary heart disease, uncontrolled hypertension, or other clinically significant cardiovascular disease, or history of a positive test for Human immuno-deficiency (HIV), Hepatitis B or Hepatitis C

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mississauga	Ontario	Canada

Sponsors and Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

• Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• ClinicalTrials.gov Identifier: NCT00804687
• Other Study ID Numbers: CR015709; 39220675ATT2001
• First Posted: Dec 9, 2008
• Last Update Posted: Oct 30, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: Allergy; Rhinitis; Allergic Rhinitis; JNJ-39220675; Pseudoephedrine
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Pseudoephedrine; Ephedrine

Study Results

Participant Flow

Arm/Group Title	JNJ-39220675 Then Pseudoephedrine Then Placebo	JNJ-39220675 Then Placebo Then Pseudoephedrine	Placebo Then JNJ-39220675 Then Pseudoephedrine	Placebo Then Pseudoephedrine Then JNJ-39220675	Pseudoephedrine Then JNJ-39220675 Then Placebo	Pseudoephedrine Then Placebo Then JNJ-39220675
Arm/Group Description	Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.	Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.	Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.	Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.	Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.	Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
Period Title: Period 1: Treatment Period
STARTED	9	9	9	9	9	8
COMPLETED	9	9	9	9	9	8
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1: Treatment Period
STARTED	9	9	9	9	9	8
COMPLETED	9	9	9	9	9	8
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1: Treatment Period
STARTED	9	9	9	9	9	8
COMPLETED	9	9	9	8	9	8
NOT COMPLETED	0	0	0	1	0	0
Period Title: Period 1: Treatment Period
STARTED	9	9	9	8	9	8
COMPLETED	9	9	9	8	9	8
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1: Treatment Period
STARTED	9	9	9	8	9	8
COMPLETED	8	9	8	8	8	8
NOT COMPLETED	1	0	1	0	1	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes all participants randomized in the study.
Overall Participants	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.9 (11.8)
Sex: Female, Male (Count of Participants)
Female	15 28.3%
Male	38 71.7%

Outcome Measures

1. Primary Outcome

Title	Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry
Description	The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.
Time Frame	2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Placebo	JNJ-39220675	Pseudoephedrine
Arm/Group Description	Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
Measure Participants	51	52	51
Mean (Standard Deviation) [square centimeter*hour (cm^2*h)]	-0.682 (0.803)	-0.504 (0.805)	-0.550 (0.843)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-39220675
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0602
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean difference
	Estimated Value	-0.126
	Confidence Interval	() 95%; -0.258 to 0.006
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.066
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Pseudoephedrine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0043
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean difference
	Estimated Value	-0.195
	Confidence Interval	() 95%; -0.328 to -0.063
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.067
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	JNJ-39220675, Pseudoephedrine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3513
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean difference
	Estimated Value	-0.066
	Confidence Interval	(2-Sided) 95%; -0.206 to 0.075
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.070
	Estimation Comments

2. Secondary Outcome

Title	Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)
Description	The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).
Time Frame	2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Placebo	JNJ-39220675	Pseudoephedrine
Arm/Group Description	Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
Measure Participants	51	52	51
Mean (Standard Deviation) [units on a scale * hours]	45.720 (24.707)	36.536 (24.322)	43.195 (26.202)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, JNJ-39220675
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean difference
	Estimated Value	8.604
	Confidence Interval	() 95%; 4.104 to 13.104
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.267
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Pseudoephedrine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0428
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean difference
	Estimated Value	4.699
	Confidence Interval	() 95%; 0.155 to 9.243
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.289
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	JNJ-39220675, Pseudoephedrine
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0895
	Comments
	Method	Linear mixed model
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean difference
	Estimated Value	-3.905
	Confidence Interval	(2-Sided) 95%; -8.424 to 0.614
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.277
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1
Description	The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.
Time Frame	0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Placebo	JNJ-39220675	Pseudoephedrine
Arm/Group Description	Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
Measure Participants	51	52	51
Change at Hour 0.5	2.7 (3.0)	1.4 (2.5)	1.7 (2.4)
Change at Hour 1	3.5 (3.5)	2.2 (2.9)	3.4 (3.6)
Change at Hour 1.5	4.1 (3.8)	3.2 (3.3)	4.2 (3.7)
Change at Hour 2	5.0 (3.6)	3.9 (3.5)	4.6 (3.8)
Change at Hour 2.5	5.6 (3.7)	4.1 (3.3)	5.0 (3.7)
Change at Hour 3.0	5.8 (3.6)	4.7 (3.5)	5.4 (3.5)
Change at Hour 3.5	5.6 (3.5)	4.9 (3.5)	5.6 (3.6)
Change at Hour 4	6.1 (3.6)	5.4 (3.3)	6.0 (3.8)
Change at Hour 4.5	6.4 (3.4)	5.3 (3.8)	5.6 (3.8)
Change at Hour 5	6.5 (3.4)	5.3 (3.7)	6.3 (3.6)
Change at Hour 5.5	6.6 (3.2)	5.4 (3.6)	6.4 (3.7)
Change at Hour 6	6.9 (3.5)	5.6 (3.5)	6.5 (3.6)
Change at Hour 6.5	7.0 (3.4)	5.7 (3.5)	6.8 (3.8)
Change at Hour 7	7.0 (3.5)	6.1 (3.5)	6.9 (3.7)
Change at Hour 7.5	7.0 (3.6)	6.1 (3.3)	6.9 (3.5)
Change at Hour 8	7.4 (3.4)	6.5 (3.3)	7.0 (3.6)

4. Secondary Outcome

Title	Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1
Description	The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.
Time Frame	Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Placebo	JNJ-39220675	Pseudoephedrine
Arm/Group Description	Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.	Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.	Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
Measure Participants	51	52	51
Baseline	0.304 (0.106)	0.294 (0.121)	0.312 (0.116)
Change at Hour 1	-0.054 (0.112)	-0.028 (0.118)	-0.035 (0.118)
Change at Hour 2	-0.048 (0.122)	-0.041 (0.112)	0.060 (0.111)
Change at Hour 3	-0.086 (0.114)	-0.055 (0.117)	-0.053 (0.115)
Change at Hour 4	-0.100 (0.105)	-0.077 (0.125)	-0.072 (0.119)
Change at Hour 5	-0.104 (0.124)	-0.082 (0.105)	-0.092 (0.127)
Change at Hour 6	-0.108 (0.117)	-0.091 (0.116)	-0.081 (0.148)
Change at Hour 7	-0.094 (0.135)	-0.079 (0.125)	-0.099 (0.124)
Change at Hour 8	-0.111 (0.119)	-0.090 (0.139)	-0.110 (0.115)

Adverse Events

Time Frame	Baseline up to End of Treatment (Day 41)
Adverse Event Reporting Description	An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Arm/Group Title	Placebo		JNJ-39220675		Pseudoephedrine
Arm/Group Description	Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.		Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.		Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
All Cause Mortality
	Placebo		JNJ-39220675		Pseudoephedrine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		JNJ-39220675		Pseudoephedrine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/52 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		JNJ-39220675		Pseudoephedrine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/51 (2%)		37/52 (71.2%)		3/51 (5.9%)
Cardiac disorders
Palpitations	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Eye disorders
Conjunctivitis allergic	1/51 (2%)		1/52 (1.9%)		0/51 (0%)
Mydriasis	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Gastrointestinal disorders
Abdominal pain	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Dry mouth	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Frequent bowel movements	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Nausea	0/51 (0%)		7/52 (13.5%)		0/51 (0%)
Metabolism and nutrition disorders
Anorexia	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Nervous system disorders
Autonomic nervous system imbalance	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Disturbance in attention	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Dizziness	0/51 (0%)		2/52 (3.8%)		0/51 (0%)
Headache	0/51 (0%)		5/52 (9.6%)		1/51 (2%)
Tremor	0/51 (0%)		0/52 (0%)		1/51 (2%)
Psychiatric disorders
Anxiety	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Insomnia	0/51 (0%)		9/52 (17.3%)		0/51 (0%)
Nightmare	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Skin and subcutaneous tissue disorders
Night sweats	0/51 (0%)		1/52 (1.9%)		0/51 (0%)
Rash	0/51 (0%)		0/52 (0%)		1/51 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.