Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
Phase 2
Completed
- Conditions
- Common Cold Associated With Cough
- Interventions
- Drug: Placebo
- Registration Number
- NCT02379637
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A N-acetylcysteine N-acetylcysteine N-acetylcysteine B Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) 72 hours Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours
- Secondary Outcome Measures
Name Time Method Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) 7 Days Number of patients with adverse advents