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

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ClinicalTrials.gov Identifier: NCT02379637
Recruitment Status : Completed
First Posted : March 5, 2015
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Common Cold Associated With Cough
Interventions Drug: N-acetylcysteine
Drug: Placebo
Enrollment 70
Recruitment Details 8 centers in canada Start date 26 Jan 2015 End date 01 Apr 2015
Pre-assignment Details Screening and randomization are on day 1 Duration of the study = 7 days
Arm/Group Title A N-acetylcysteine B Placebo
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N-acetylcysteine

N-acetylcysteine, capsules, 800 mg 3 times daily

Placebo

Placebo, matching capsules three times daily

Period Title: Overall Study
Started 35 35
Completed 33 34
Not Completed 2 1
Reason Not Completed
Protocol Violation             0             1
Adverse Event             1             0
Withdrawal by Subject             1             0
Arm/Group Title A N-acetylcysteine B Placebo Total
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N-acetylcysteine

N-acetylcysteine

Placebo

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
33  (11.06) 34  (12.9) 33.5  (11.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
23
  65.7%
23
  65.7%
46
  65.7%
Male
12
  34.3%
12
  34.3%
24
  34.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 35 participants 35 participants 70 participants
35 35 70
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 35 participants 35 participants 70 participants
26.3  (4.49) 27.3  (4.59) 26.8  (4.53)
1.Primary Outcome
Title Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
Hide Description Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours
Time Frame 72 hours
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Hide Analysis Population Description
Full Analysis set
Arm/Group Title A N-acetylcysteine B Placebo
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N-acetylcysteine

N-acetylcysteine

Placebo

Placebo

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: log-transformed total cough count
6.92  (0.95) 6.51  (0.83)
2.Secondary Outcome
Title Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
Hide Description Number of patients with adverse advents
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A N-acetylcysteine B Placebo
Hide Arm/Group Description:

N-acetylcysteine

N-acetylcysteine

Placebo

Placebo

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: participants
4 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A N-acetylcysteine B Placebo
Hide Arm/Group Description

N-acetylcysteine

N-acetylcysteine

Placebo

Placebo

All-Cause Mortality
A N-acetylcysteine B Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A N-acetylcysteine B Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
A N-acetylcysteine B Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/35 (5.71%)      2/35 (5.71%)    
Gastrointestinal disorders     
Dyspepsia  1  2/35 (5.71%)  2 2/35 (5.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor shall review results communications prior to public release to evaluate the manuscript for accuracy, ascertain whether information (other than the results of the Clinical Trial) is being improperly disclosed, provided information which may have not have yet been made available by the Sponsor, provide input for consideration regarding the content and/or conclusion(s) of the manuscript and determine whether the manuscript discloses any potentially patentable invention(s).
Results Point of Contact
Name/Title: Dr Marianna Armogida Director Clinical Research Innovation
Organization: Novartis
Phone: +41223635182
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT02379637     History of Changes
Other Study ID Numbers: 2160-A-201
First Submitted: February 13, 2015
First Posted: March 5, 2015
Results First Submitted: March 30, 2016
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016