Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough

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

This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.

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