Common Cold Associated With Cough Clinical Trial
— NAC cold coughOfficial title:
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
| Verified date | April 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cough Count (Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours) | Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours | 72 hours | No |
| Secondary | Cough and Cold Symptoms Wisconsin Upper Respiratory Symptom Survey score (WURSS-11) and the Leicester Cough Questionnaire (LCQ-acute) quality of life assessment | Will be measured by subject reporting symptoms using the Wisconsin Upper Respiratory Symptom Survey score (WURSS-11) and the Leicester Cough Questionnaire (LCQ-acute) quality of life assessment for 7 days | 7 days | No |
| Secondary | Safety of Daily Dose of NAC (Number of patients with adverse advents) | Number of patients with adverse advents | 7 Days | No |
| Secondary | Cough Frequency over 24 Hours | Number of coughs within a 24-hour time period wlil be measured by a 24-hour ambulatory cough monitoring system for 7 days | 7 Days | No |
| Secondary | Maintenance of Benefit (If the subject felt that the investigational drug provided any benefit) | If the subject felt that the investigational drug provided any benefit | 7 days | No |
| Secondary | Sputum Production (Number of times subject reported sputum production for 7 days) | Number of times subject reported sputum production for 7 days | 7 days | No |