NCT00394914

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

A Placebo-Controlled Study of the Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Common Cold
• Picornavirus Infection
• Rhinovirus

Interventions

Type	Name	Description
DRUG	Pleconaril	Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.
DRUG	Placebo to Pleconaril	Placebo nasal suspension

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-11-02
• Last updated: 2015-07-16
• Results posted: 2013-10-31