The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00276016
• Collaborator: (none)
• Enrollment: 39
• Arms: 6
• Duration (Months): 1

Study Details

Study Description

Brief Summary

This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Seasonal	Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenylephrine, Pseudoephedrine, Placebo Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.	Drug: phenylephrine; immediate-release 12 mg capsules for oral administration; Drug: pseudoephedrine; 60 mg immediate-release tablets for oral administration; Drug: placebo; placebo capsules
Experimental: Pseudoephedrine, Placebo, Phenylephrine Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.	Drug: phenylephrine; immediate-release 12 mg capsules for oral administration; Drug: pseudoephedrine; 60 mg immediate-release tablets for oral administration; Drug: placebo; placebo capsules
Experimental: Placebo, Phenylephrine, Pseudoephedrine Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Drug: phenylephrine; immediate-release 12 mg capsules for oral administration; Drug: pseudoephedrine; 60 mg immediate-release tablets for oral administration; Drug: placebo; placebo capsules
Experimental: Phenylephrine, Placebo, Pseudoephedrine Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Drug: phenylephrine; immediate-release 12 mg capsules for oral administration; Drug: pseudoephedrine; 60 mg immediate-release tablets for oral administration; Drug: placebo; placebo capsules
Experimental: Pseudoephedrine, Phenylephrine, Placebo Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.	Drug: phenylephrine; immediate-release 12 mg capsules for oral administration; Drug: pseudoephedrine; 60 mg immediate-release tablets for oral administration; Drug: placebo; placebo capsules
Experimental: Placebo, Pseudoephedrine, Phenylephrine Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.	Drug: phenylephrine; immediate-release 12 mg capsules for oral administration; Drug: pseudoephedrine; 60 mg immediate-release tablets for oral administration; Drug: placebo; placebo capsules

Outcome Measures

Primary Outcome Measures

1. The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo [Baseline to endpoint (6 hour period)]

   To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.

Secondary Outcome Measures

1. The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. [Baseline to endpoint (6 hour period)]

   To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Skin test positive for the grass pollen allergen used in the chamber at Screening or within the prior 12 months.

• A negative urine pregnancy test at Screening and at monthly intervals for female subjects of childbearing potential.

• The following minimum scores at an evaluation time point during each of the 120-minute screening period challenge sessions:

1. Nasal Congestion Score of at least 2 (moderate);

2. Total Nasal Symptoms Score of at least 6;

3. Total Non-nasal Symptoms Score of at least 2.

• Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.

Exclusion Criteria :

• An upper or lower respiratory tract infection within 4 weeks before Screening.

• Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.

• A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00276016
• Other Study ID Numbers: P04579
• First Posted: Jan 12, 2006
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Phenylephrine; Oxymetazoline; Pseudoephedrine; Ephedrine

Study Results

Participant Flow

Pre-assignment Detail	1 subject discontinued for reasons unrelated to treatment with study drug after the first dose (Intervention 1) of study drug Pseudoephedrine(PSE)

Arm/Group Title	Phenylephrine, Pseudoephedrine, Placebo	Pseudoephedrine, Placebo, Phenylephrine	Placebo, Phenylephrine, Pseudoephedrine	Phenylephrine, Placebo, Pseudoephedrine	Pseudoephedrine, Phenylephrine, Placebo	Placebo, Pseudoephedrine, Phenylephrine
Arm/Group Description	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.	Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.	Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
Period Title: Intervention 1
STARTED	7	7	7	6	6	6
COMPLETED	7	6	7	6	6	6
NOT COMPLETED	0	1	0	0	0	0
Period Title: Intervention 1
STARTED	7	6	7	6	6	6
COMPLETED	7	6	7	6	6	6
NOT COMPLETED	0	0	0	0	0	0
Period Title: Intervention 1
STARTED	7	6	7	6	6	6
COMPLETED	7	6	7	6	6	6
NOT COMPLETED	0	0	0	0	0	0
Period Title: Intervention 1
STARTED	7	6	7	6	6	6
COMPLETED	7	6	7	6	6	6
NOT COMPLETED	0	0	0	0	0	0
Period Title: Intervention 1
STARTED	7	6	7	6	6	6
COMPLETED	7	6	7	6	6	6
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Phenylephrine, Pseudoephedrine, Placebo	Pseudoephedrine, Placebo, Phenylephrine	Placebo, Phenylephrine, Pseudoephedrine	Phenylephrine, Placebo, Pseudoephedrine	Pseudoephedrine, Phenylephrine, Placebo	Placebo, Pseudoephedrine, Phenylephrine	Total
Arm/Group Description	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.	Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.	Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration	Total of all reporting groups
Overall Participants	7	7	7	6	6	6	39
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.9 (9.0)	27.9 (3.3)	24.9 (3.5)	26.3 (1.6)	28.0 (7.1)	27.3 (3.3)	27.0 (5.1)
Sex: Female, Male (Count of Participants)
Female	5 71.4%	5 71.4%	4 57.1%	1 16.7%	3 50%	5 83.3%	23 59%
Male	2 28.6%	2 28.6%	3 42.9%	5 83.3%	3 50%	1 16.7%	16 41%

Outcome Measures

1. Primary Outcome

Title	The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
Description	To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
Time Frame	Baseline to endpoint (6 hour period)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Phenylephrine
Arm/Group Description
Measure Participants	38	38
Baseline score	2.20 (0.36)	2.20 (0.36)
Change from Baseline to Endpoint Score	-0.12 (0.44)	-0.18 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Phenylephrine
	Comments	For endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.561
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
Description	To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
Time Frame	Baseline to endpoint (6 hour period)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pseudoephedrine	Placebo
Arm/Group Description
Measure Participants	39	38
Baseline	2.26 (0.36)	2.20 (0.36)
Endpoint	-0.47 (0.44)	-0.12 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Phenylephrine
	Comments	For endpoint
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	ANOVA
	Comments

Adverse Events

Arm/Group Title	Phenylephrine		Pseudoephedrine		Placebo
Arm/Group Description	Phenylephrine: Immediate-release 12 mg capsules for oral administration.		Pseudoephedrine: 60 mg immediate-release tablets for oral administration.		Placebo: Placebo capsules.
All Cause Mortality
	Phenylephrine		Pseudoephedrine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Phenylephrine		Pseudoephedrine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Phenylephrine		Pseudoephedrine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)		0/39 (0%)

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.