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

Common Cold Associated With Cough Clinical Trial

— NAC cold cough  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379637
• Other study ID #: 2160-A-201
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2015
• Last updated: April 2, 2015
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold
• Common Cold Associated With Cough
• Cough

Intervention

Drug:
• N-acetylcysteine

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Canada, 

Outcome

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