Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)

Summary

This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.

Timeline

Start

2006-08

Primary completion

2007-04

Completion

2007-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Pleconaril vs Placebo; p = 0.973; Cochran-Mantel-Haenszel NCT00394914 ↗

registry analysis (superiority or other test); Pleconaril vs Placebo; p = 0.425; Cochran-Mantel-Haenszel NCT00394914 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pleconaril	Small molecule	12 mg	Intranasal

Indications