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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00394914 |
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 subjects exposed to picornavirus respiratory infections. Subjects will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Subjects will be followed for an additional 14 days.
Condition | Intervention | Phase |
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Asthma Common Cold Picornavirus Infection Rhinovirus |
Drug: Pleconaril |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled Study of the Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure |
Ages Eligible for Study: | 6 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must have a history of two or more upper respiratory infection-induced asthma exacerbations in the past 24 months.
Exclusion Criteria:
Study ID Numbers: | P04295, Doc ID: 3303796;, SCH 900819 |
Study First Received: | October 31, 2006 |
Last Updated: | June 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00394914 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bronchial Diseases Picornaviridae Infections Asthma Pleconaril Antiviral Agents Virus Diseases Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Common Cold Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |
Anti-Infective Agents RNA Virus Infections Bronchial Diseases Immune System Diseases Pleconaril Asthma Picornaviridae Infections Infection Antiviral Agents Pharmacologic Actions |
Virus Diseases Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Common Cold Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Respiratory Hypersensitivity |