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

Novartis

Status and phase: Completed; Phase 2

Conditions: Common Cold Associated With Cough

Treatments: Drug: N-acetylcysteine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02379637

2160-A-201

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

A N-acetylcysteine

Experimental group

Description:

N-acetylcysteine

Treatment:

Drug: N-acetylcysteine

B Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo