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

NCT ID: NCT00276016

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phenylephrine, Pseudoephedrine, Placebo

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Placebo: Placebo capsules.

Group Type: EXPERIMENTAL

phenylephrine

Intervention Type: DRUG

immediate-release 12 mg capsules for oral administration

pseudoephedrine

Intervention Type: DRUG

60 mg immediate-release tablets for oral administration

placebo

Intervention Type: DRUG

placebo capsules

Pseudoephedrine, Placebo, Phenylephrine

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Placebo: Placebo capsules.

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Group Type: EXPERIMENTAL

phenylephrine

Intervention Type: DRUG

immediate-release 12 mg capsules for oral administration

pseudoephedrine

Intervention Type: DRUG

60 mg immediate-release tablets for oral administration

placebo

Intervention Type: DRUG

placebo capsules

Placebo, Phenylephrine, Pseudoephedrine

Placebo: Placebo capsules.

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Group Type: EXPERIMENTAL

phenylephrine

Intervention Type: DRUG

immediate-release 12 mg capsules for oral administration

pseudoephedrine

Intervention Type: DRUG

60 mg immediate-release tablets for oral administration

placebo

Intervention Type: DRUG

placebo capsules

Phenylephrine, Placebo, Pseudoephedrine

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Placebo: Placebo capsules.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Group Type: EXPERIMENTAL

phenylephrine

Intervention Type: DRUG

immediate-release 12 mg capsules for oral administration

pseudoephedrine

Intervention Type: DRUG

60 mg immediate-release tablets for oral administration

placebo

Intervention Type: DRUG

placebo capsules

Pseudoephedrine, Phenylephrine, Placebo

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Placebo: Placebo capsules.

Group Type: EXPERIMENTAL

phenylephrine

Intervention Type: DRUG

immediate-release 12 mg capsules for oral administration

pseudoephedrine

Intervention Type: DRUG

60 mg immediate-release tablets for oral administration

placebo

Intervention Type: DRUG

placebo capsules

Placebo, Pseudoephedrine, Phenylephrine

Placebo: Placebo capsules.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Group Type: EXPERIMENTAL

phenylephrine

Intervention Type: DRUG

immediate-release 12 mg capsules for oral administration

pseudoephedrine

Intervention Type: DRUG

60 mg immediate-release tablets for oral administration

placebo

Intervention Type: DRUG

placebo capsules

Interventions

phenylephrine

immediate-release 12 mg capsules for oral administration

Intervention Type: DRUG

pseudoephedrine

60 mg immediate-release tablets for oral administration

Intervention Type: DRUG

placebo

placebo capsules

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 19230461 (View on PubMed)

Other Identifiers

P04579

Identifier Type: -

Identifier Source: org_study_id