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

Organon

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: pseudoephedrine; Drug: phenylephrine; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276016

P04579

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

39 participants in 6 patient groups

Phenylephrine, Pseudoephedrine, Placebo

Experimental group

Description:

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

Treatment:

Drug: pseudoephedrine

Drug: phenylephrine

Drug: placebo

Pseudoephedrine, Placebo, Phenylephrine

Experimental group

Description:

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

Treatment:

Drug: pseudoephedrine

Drug: phenylephrine

Drug: placebo

Placebo, Phenylephrine, Pseudoephedrine

Experimental group

Description:

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

Treatment:

Drug: pseudoephedrine

Drug: phenylephrine

Drug: placebo

Phenylephrine, Placebo, Pseudoephedrine

Experimental group

Description:

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

Treatment:

Drug: pseudoephedrine

Drug: phenylephrine

Drug: placebo

Pseudoephedrine, Phenylephrine, Placebo

Experimental group

Description:

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

Treatment:

Drug: pseudoephedrine

Drug: phenylephrine

Drug: placebo

Placebo, Pseudoephedrine, Phenylephrine

Experimental group

Description:

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

Treatment:

Drug: pseudoephedrine

Drug: phenylephrine

Drug: placebo