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

NCT00276016 | Completed Phase 3 Results

• 1 other identifier: P04579
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (1)

• The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo

  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.

  Baseline to endpoint (6 hour period)

Secondary Outcomes (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)

Study Arms (6)

Phenylephrine, Pseudoephedrine, Placebo

EXPERIMENTAL

Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.

Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo

Pseudoephedrine, Placebo, Phenylephrine

EXPERIMENTAL

Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo

Placebo, Phenylephrine, Pseudoephedrine

EXPERIMENTAL

Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo

Phenylephrine, Placebo, Pseudoephedrine

EXPERIMENTAL

Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo

Pseudoephedrine, Phenylephrine, Placebo

EXPERIMENTAL

Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.

Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo

Placebo, Pseudoephedrine, Phenylephrine

EXPERIMENTAL

Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo

Interventions

phenylephrine DRUG

immediate-release 12 mg capsules for oral administration

Phenylephrine, Placebo, Pseudoephedrine; Phenylephrine, Pseudoephedrine, Placebo; Placebo, Phenylephrine, Pseudoephedrine; Placebo, Pseudoephedrine, Phenylephrine; Pseudoephedrine, Phenylephrine, Placebo; Pseudoephedrine, Placebo, Phenylephrine

pseudoephedrine DRUG

60 mg immediate-release tablets for oral administration

Phenylephrine, Placebo, Pseudoephedrine; Phenylephrine, Pseudoephedrine, Placebo; Placebo, Phenylephrine, Pseudoephedrine; Placebo, Pseudoephedrine, Phenylephrine; Pseudoephedrine, Phenylephrine, Placebo; Pseudoephedrine, Placebo, Phenylephrine

placebo DRUG

placebo capsules

Phenylephrine, Placebo, Pseudoephedrine; Phenylephrine, Pseudoephedrine, Placebo; Placebo, Phenylephrine, Pseudoephedrine; Placebo, Pseudoephedrine, Phenylephrine; Pseudoephedrine, Phenylephrine, Placebo; Pseudoephedrine, Placebo, Phenylephrine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Nasal Congestion Score of at least 2 (moderate);
• Total Nasal Symptoms Score of at least 6;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Yao R, Staudinger H, Danzig M. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Ann Allergy Asthma Immunol. 2009 Feb;102(2):116-20. doi: 10.1016/S1081-1206(10)60240-2.

  PMID: 19230461 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Phenylephrine; Pseudoephedrine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propanolamines; Propanols; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 12, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: February 9, 2022
• Results First Posted: July 29, 2010

Record last verified: 2022-02