Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
NAC cold 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
1 other identifier
interventional
70
1 country
5
Brief Summary
This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2015
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
July 11, 2016
CompletedJuly 11, 2016
May 1, 2016
3 months
February 13, 2015
March 30, 2016
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
7 Days
Study Arms (2)
A N-acetylcysteine
EXPERIMENTALN-acetylcysteine
B Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
Unknown Facility
Chicoutimi, Quebec, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Sherbrook, Quebec, Canada
Unknown Facility
Victoriaville, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Marianna Armogida Director Clinical Research Innovation
- Organization
- Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2015
First Posted
March 5, 2015
Study Start
January 1, 2015
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 11, 2016
Results First Posted
July 11, 2016
Record last verified: 2016-05