Trial Outcomes & Findings for Moderate to Persistent Asthma in the Obese Subject (NCT NCT01016847)
NCT ID: NCT01016847
Last Updated: 2014-11-17
Results Overview
TERMINATED
PHASE4
38 participants
Baseline/randomization to week 16
2014-11-17
Participant Flow
38 subjects enrolled in study. Of the 38 subjects 10 were screen failures, and 25 were withdrawn during the 2 week run-in period.
Participant milestones
| Measure |
Leukotriene Receptor Antagonist (LTRA) Montelukast
Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day
|
Sugar Pill
High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Moderate to Persistent Asthma in the Obese Subject
Baseline characteristics by cohort
| Measure |
Leukotriene Receptor Antagonist (LTRA) Montelukast
n=1 Participants
Montelukast (LTRA) administered with moderate dose of inhaled steroid
Montelukast: 10 mg Q day
|
Sugar Pill
n=2 Participants
High dose of inhaled steroid administered with sugar pill
Sugar pill: Sugar pill that looks like Montelukast that will be given Q day
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline/randomization to week 16Population: Due to insufficient accrual, data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline/randomization to week 16Population: Due to insufficient accrual, data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline/randomization to week 16Population: Due to insufficient accrual, data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline/randomization to week 16Population: Due to insufficient accrual, data analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline/randomization to week 16Population: Due to insufficient accrual, data analysis was not performed.
Asthma exacerbation is defined as the development of an increase in asthma symptoms which results in an increase in the use of asthma medications (typically inhaled corticosteroids and/or parenteral corticosteroids) or the addition of another new asthma medication or antibiotics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline/randomization to week 16Population: Due to insufficient accrual, data analysis was not performed.
Outcome measures
Outcome data not reported
Adverse Events
Leukotriene Receptor Antagonist (LTRA) Montelukast
Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place