Phase 2
N=70
Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
Common Cold Associated With Cough
Bottom Line
View on ClinicalTrials.gov: NCT02379637 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) — 6.92; 6.51 log-transformed total cough count
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) |
6.92; 6.51 | — |
| SECONDARY Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) |
4; 4 | — |
Summary
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
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
Data sourced from ClinicalTrials.gov (NCT02379637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.