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A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe, Refractory Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT00994175
First received: October 10, 2009
Last updated: August 1, 2017
Last verified: August 2017
Results First Received: June 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Severe, Refractory Asthma
Airway Inflammation
Airflow Obstruction
Interventions: Drug: Pioglitazone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   First Intervention
    Pioglitazone, Then Placebo   Placebo, Then Pioglitazone
STARTED   6   9 
COMPLETED   4   8 
NOT COMPLETED   2   1 

Period 2:   Second Intervention
    Pioglitazone, Then Placebo   Placebo, Then Pioglitazone
STARTED   4   8 
COMPLETED   4   8 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Participants All subjects who started the study.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11  73.3% 
>=65 years      4  26.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  53.3% 
Male      7  46.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   6.7% 
Not Hispanic or Latino      14  93.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   6.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2  13.3% 
White      11  73.3% 
More than one race      1   6.7% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   16 Weeks - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score   [ Time Frame: 16 weeks ]

2.  Primary:   Baseline - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Levine, Stewart
Organization: National Heart Lung and Blood Institute
phone: +1 301 402 1448
e-mail: levines@nhlbi.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT00994175     History of Changes
Other Study ID Numbers: 090244
09-H-0244 ( Other Identifier: The National Institutes of Health )
Study First Received: October 10, 2009
Results First Received: June 16, 2017
Last Updated: August 1, 2017