Trial Outcomes & Findings for Clinical Trial of NAC in Asthma (NCT NCT02605824)
NCT ID: NCT02605824
Last Updated: 2019-08-20
Results Overview
This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.
TERMINATED
PHASE4
1 participants
7 days
2019-08-20
Participant Flow
9 subjects were consented to the study but only one remained eligible to continue to the treatment period after baseline eligibility testing and the run-in period.
Participant milestones
| Measure |
20% N-acetylcystine (NAC)
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.
n-acetylcystine: NAC is a mucolytic drug.
|
0.9% Saline
Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.
0.9% saline: Normal saline is a placebo agent.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
20% N-acetylcystine (NAC)
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.
n-acetylcystine: NAC is a mucolytic drug.
|
0.9% Saline
Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.
0.9% saline: Normal saline is a placebo agent.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Clinical Trial of NAC in Asthma
Baseline characteristics by cohort
| Measure |
20% N-acetylcystine (NAC)
n=1 Participants
NAC (trade name: Mucomyst) is manufactured by American Regent. The active drug studied here is 20% NAC delivered via nebulizer three times per day for seven days.
n-acetylcystine: NAC is a mucolytic drug.
|
0.9% Saline
Normal saline will be administered as the placebo agent via a nebulizer three times per day for seven days.
0.9% saline: Normal saline is a placebo agent.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Only one subject was enrolled into the intervention, and after taking the first dose of NAC, they experienced excessive bronchospasm thus making them ineligible to continue and complete the study.
This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Only one subject was enrolled into the intervention, and after taking the first dose of NAC, they experienced excessive bronchospasm thus making them ineligible to continue and complete the study.
The CT Mucus Score describes the number of segments of the lungs that are impacted by mucus. This outcome will compare the change in CT mucus score both at baseline and following each treatment period.
Outcome measures
Outcome data not reported
Adverse Events
20% N-acetylcystine (NAC)
0.9% Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Fahy Research Manager
UCSF Airway Clinical Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place