NCT02379637
Completed
Phase 2
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof-of-Concept Study to Evaluate the Efficacy of N-acetylcysteine Capsules in the Treatment of the Common Cold (Viral URTI) Associated With Cough in an Adult Population
ConditionsCommon Cold Associated With Cough
Overview
- Phase
- Phase 2
- Intervention
- N-acetylcysteine
- Conditions
- Common Cold Associated With Cough
- Sponsor
- Novartis
- Enrollment
- 70
- Primary Endpoint
- Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cold/URTI symptoms occurring no more than 4 days
- •cough due to a cold or acute viral (URTI) with an onset of no more than 3 days
- •cough frequency with specified cut-off
Exclusion Criteria
- •A subchronic, or chronic cough (cough duration \> 2 months) due to any condition other than a cold/URTI
- •Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis
- •Taking any medications known to induce cough
- •Fever of greater than 39°C (102°F) orally
- •Complication of the common cold like otitis media, severe sinusitis, or pneumonia
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
A N-acetylcysteine
N-acetylcysteine
Intervention: N-acetylcysteine
B Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
Time Frame: 72 hours
Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours
Secondary Outcomes
- Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)(7 Days)
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