Trial Outcomes & Findings for Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough (NCT NCT02379637)
NCT ID: NCT02379637
Last Updated: 2016-07-11
Results Overview
Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
72 hours
Results posted on
2016-07-11
Participant Flow
8 centers in canada Start date 26 Jan 2015 End date 01 Apr 2015
Screening and randomization are on day 1 Duration of the study = 7 days
Participant milestones
| Measure |
A N-acetylcysteine
N-acetylcysteine
N-acetylcysteine, capsules, 800 mg 3 times daily
|
B Placebo
Placebo
Placebo, matching capsules three times daily
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
A N-acetylcysteine
N-acetylcysteine
N-acetylcysteine, capsules, 800 mg 3 times daily
|
B Placebo
Placebo
Placebo, matching capsules three times daily
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
Baseline characteristics by cohort
| Measure |
A N-acetylcysteine
n=35 Participants
N-acetylcysteine
N-acetylcysteine
|
B Placebo
n=35 Participants
Placebo
Placebo
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
34 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 11.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Body mass index
|
26.3 kg/m^2
STANDARD_DEVIATION 4.49 • n=5 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 4.59 • n=7 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 4.53 • n=5 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Full Analysis set
Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours
Outcome measures
| Measure |
A N-acetylcysteine
n=35 Participants
N-acetylcysteine
N-acetylcysteine
|
B Placebo
n=35 Participants
Placebo
Placebo
|
|---|---|---|
|
Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
|
6.92 log-transformed total cough count
Standard Deviation 0.95
|
6.51 log-transformed total cough count
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 7 DaysNumber of patients with adverse advents
Outcome measures
| Measure |
A N-acetylcysteine
n=35 Participants
N-acetylcysteine
N-acetylcysteine
|
B Placebo
n=35 Participants
Placebo
Placebo
|
|---|---|---|
|
Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
|
4 participants
|
4 participants
|
Adverse Events
A N-acetylcysteine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
B Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A N-acetylcysteine
n=35 participants at risk
N-acetylcysteine
N-acetylcysteine
|
B Placebo
n=35 participants at risk
Placebo
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Number of events 2
|
5.7%
2/35 • Number of events 2
|
Additional Information
Dr Marianna Armogida Director Clinical Research Innovation
Novartis
Phone: +41223635182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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).
- Publication restrictions are in place
Restriction type: OTHER