Trial Outcomes & Findings for Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (NCT NCT00634036)
NCT ID: NCT00634036
Last Updated: 2017-07-19
Results Overview
Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by \> 20% from pre-methacholine baseline values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-07-19
Participant Flow
Participant milestones
| Measure |
Pioglitazone
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
matching placebo (inert tablet)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Pioglitazone
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
matching placebo (inert tablet)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=12 Participants
pioglitazone: pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
n=11 Participants
placebo: matching placebo (inert tablet)
|
Total
n=23 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
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 10 • n=5 Participants
|
41 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 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
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Age asthma onset
|
15 years
STANDARD_DEVIATION 11 • n=5 Participants
|
21 years
STANDARD_DEVIATION 18.9 • n=7 Participants
|
18 years
STANDARD_DEVIATION 14.95 • n=5 Participants
|
|
Body Mass Index
|
38.8 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
43.5 kg/m^2
STANDARD_DEVIATION 7.8 • n=7 Participants
|
41.15 kg/m^2
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Seasonal allergies
Reported allergies
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Seasonal allergies
Non-allergic
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Gastroesophageal Reflux Disease (GERD)
Participants with GERD
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Gastroesophageal Reflux Disease (GERD)
Participants without GERD
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Depression
Participants reporting Depression
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Depression
Participants without Depression
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Asthma exacerbation in last 12 months
Reported an exacerbation
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Asthma exacerbation in last 12 months
No reported exacerbation
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Oral steroids in last 12 months
Used oral steroids
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Oral steroids in last 12 months
Did not use oral steroids
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Inhaled corticosteroid
High dose
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Inhaled corticosteroid
Medium dose
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Inhaled corticosteroid
Low dose
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Long acting beta agonist
Used long acting beta agonist
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Long acting beta agonist
Did not use long acting beta agonist
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Short acting beta agonist
Used short acting beta agonist
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Short acting beta agonist
Did not use short acting beta agonist
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Exhaled Nitric Oxide
|
27.6 ppb
STANDARD_DEVIATION 27.8 • n=5 Participants
|
30.8 ppb
STANDARD_DEVIATION 28.4 • n=7 Participants
|
29.2 ppb
STANDARD_DEVIATION 28.1 • n=5 Participants
|
|
Immunoglobulin E
|
291.2 IU/ml
STANDARD_DEVIATION 313.2 • n=5 Participants
|
575 IU/ml
STANDARD_DEVIATION 544.7 • n=7 Participants
|
433.1 IU/ml
STANDARD_DEVIATION 428.95 • n=5 Participants
|
|
Juniper Asthma Control
|
1.75 scores on a scale
STANDARD_DEVIATION .63 • n=5 Participants
|
2.48 scores on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
2.115 scores on a scale
STANDARD_DEVIATION .965 • n=5 Participants
|
|
FEV1 (% predicted before bronchodilator use)
|
82.3 % predicted
STANDARD_DEVIATION 12.1 • n=5 Participants
|
81.5 % predicted
STANDARD_DEVIATION 15.2 • n=7 Participants
|
81.9 % predicted
STANDARD_DEVIATION 13.65 • n=5 Participants
|
|
FVC (% predicted before bronchodilator use)
|
86.8 % predicted
STANDARD_DEVIATION 13.7 • n=5 Participants
|
85.3 % predicted
STANDARD_DEVIATION 16.2 • n=7 Participants
|
86.05 % predicted
STANDARD_DEVIATION 14.95 • n=5 Participants
|
|
FEV1/FVC (% predicted before bronchodilator use)
|
95.3 % predicted
STANDARD_DEVIATION 11.2 • n=5 Participants
|
94.9 % predicted
STANDARD_DEVIATION 11.12 • n=7 Participants
|
95.1 % predicted
STANDARD_DEVIATION 11.16 • n=5 Participants
|
|
FEV1 (% predicted after bronchodilator use)
|
77.3 % predicted
STANDARD_DEVIATION 25.1 • n=5 Participants
|
88.1 % predicted
STANDARD_DEVIATION 4.6 • n=7 Participants
|
82.7 % predicted
STANDARD_DEVIATION 14.85 • n=5 Participants
|
|
FVC (% predicted after bronchodilator use)
|
79.5 % predicted
STANDARD_DEVIATION 27.6 • n=5 Participants
|
88.3 % predicted
STANDARD_DEVIATION 16.3 • n=7 Participants
|
83.9 % predicted
STANDARD_DEVIATION 21.95 • n=5 Participants
|
|
FEV1/FVC (% predicted after bronchodilator use)
|
90.9 % predicted
STANDARD_DEVIATION 31.2 • n=5 Participants
|
97.8 % predicted
STANDARD_DEVIATION 7.82 • n=7 Participants
|
94.35 % predicted
STANDARD_DEVIATION 19.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPresence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by \> 20% from pre-methacholine baseline values.
Outcome measures
| Measure |
Pioglitazone
n=10 Participants
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
n=9 Participants
matching placebo (inert tablet)
|
|---|---|---|
|
Airway Reactivity
|
5.08 mg/ml
Interval 0.0 to 7.42
|
2.37 mg/ml
Interval 0.0 to 11.22
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Pioglitazone
n=10 Participants
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
n=9 Participants
matching placebo (inert tablet)
|
|---|---|---|
|
FEV1 % Predicted
|
80.3 % predicted
Standard Deviation 15
|
85.2 % predicted
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 12 weeksThe Juniper Asthma Control Questionnaire is a validated scale ranging from 0 to 6. Higher scores represent poorer asthma control. Values \> 1.5 are compatible with poorly controlled asthma
Outcome measures
| Measure |
Pioglitazone
n=10 Participants
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
n=9 Participants
matching placebo (inert tablet)
|
|---|---|---|
|
Juniper Asthma Control Questionnaire
|
1.62 Scores on a scale
Standard Deviation .6
|
1.82 Scores on a scale
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Pioglitazone
n=10 Participants
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
n=9 Participants
matching placebo (inert tablet)
|
|---|---|---|
|
Exhaled Nitric Oxide Ppb
|
27.6 ppb
Standard Deviation 27.8
|
30.8 ppb
Standard Deviation 28.4
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=12 participants at risk
pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
|
Placebo
n=11 participants at risk
matching placebo (inert tablet)
|
|---|---|---|
|
General disorders
Headache
|
58.3%
7/12
|
36.4%
4/11
|
|
General disorders
Dizziness
|
8.3%
1/12
|
27.3%
3/11
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/12
|
36.4%
4/11
|
|
General disorders
Sore Throat
|
41.7%
5/12
|
18.2%
2/11
|
|
General disorders
Abdominal pain
|
25.0%
3/12
|
45.5%
5/11
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12
|
9.1%
1/11
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12
|
36.4%
4/11
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
8.3%
1/12
|
9.1%
1/11
|
|
General disorders
Muscle aches
|
25.0%
3/12
|
36.4%
4/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place