Trial Outcomes & Findings for A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma (NCT NCT00994175)
NCT ID: NCT00994175
Last Updated: 2017-09-05
Results Overview
Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
16 weeks
Results posted on
2017-09-05
Participant Flow
Participant milestones
| Measure |
Pioglitazone, Then Placebo
Pioglitazone, 30 mg daily, was administered for the initial 2 weeks of the first treatment phase, followed by 45 mg daily for an additional 14 weeks. This was followed by a 4-week washout period. Subjects were assessed for clinical stability during a second 4-week run-in period prior to crossing over to the placebo phase for 16 weeks in the second treatment phase to receive the placebo.
|
Placebo, Then Pioglitazone
Placebo was administered for 16 weeks. This was followed by a 4-week washout period. Subjects were assessed for clinical stability during a second 4-week run-in period prior to crossing over to the Pioglitazone treatment group. Pioglitazone, 30 mg daily, was administered for the initial 2 weeks of the treatment phase, followed by 45 mg daily for an additional 14 weeks.
|
|---|---|---|
|
First Intervention
STARTED
|
6
|
9
|
|
First Intervention
COMPLETED
|
4
|
8
|
|
First Intervention
NOT COMPLETED
|
2
|
1
|
|
Second Intervention
STARTED
|
4
|
8
|
|
Second Intervention
COMPLETED
|
4
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
All subjects who started the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All subjects who completed both treatment phases of the study
Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired
Outcome measures
| Measure |
Pioglitazone
n=12 Participants
Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
|
Placebo
n=12 Participants
Subjects received a matched placebo.
|
|---|---|---|
|
16 Weeks - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score
|
4.7 units on a scale
Standard Deviation 1.3
|
4.6 units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: BaselinePopulation: All subjects who completed both treatment phases of the study
Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired
Outcome measures
| Measure |
Pioglitazone
n=12 Participants
Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
|
Placebo
n=12 Participants
Subjects received a matched placebo.
|
|---|---|---|
|
Baseline - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score
|
4.478 units on a scale
Standard Deviation 0.9866
|
4.306 units on a scale
Standard Deviation 1.342
|
Adverse Events
Pioglitazone
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone
n=15 participants at risk
Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
|
Placebo
n=15 participants at risk
Subjects received a matched placebo.
|
|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
General disorders
Allergic oedema
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Immune system disorders
Allergic oedema
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
Other adverse events
| Measure |
Pioglitazone
n=15 participants at risk
Subjects received 30 mg daily of pioglitazone for the first 2 weeks of the treatment phase and then were escalated to 45 mg daily of pioglitazone for the 3rd through 16th weeks of the treatment phase
|
Placebo
n=15 participants at risk
Subjects received a matched placebo.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Eye disorders
Conjunctivitis
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Eye disorders
Retinal tear
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Gastrointestinal disorders
Oral infection
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
General disorders
Cyst
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
General disorders
Oedema
|
20.0%
3/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
General disorders
Swelling
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Infections and infestations
Nail infection
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15 • 44 weeks
|
20.0%
3/15 • 44 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Investigations
Weight increased
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.3%
2/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Renal and urinary disorders
Genitourinary symptom
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
1/15 • 44 weeks
|
40.0%
6/15 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.7%
1/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • 44 weeks
|
6.7%
1/15 • 44 weeks
|
|
Surgical and medical procedures
Rabies immunisation
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • 44 weeks
|
0.00%
0/15 • 44 weeks
|
Additional Information
Levine, Stewart
National Heart Lung and Blood Institute
Phone: +1 301 402 1448
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place