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Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (GLITZ Asthma)

This study has been completed.
Sponsor:
Collaborators:
Takeda
University of Vermont
Information provided by (Responsible Party):
Fernando Holguin, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00634036
First received: March 5, 2008
Last updated: June 19, 2017
Last verified: June 2017
Results First Received: March 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
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
No text entered.

Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    Pioglitazone   Placebo
STARTED   12   11 
COMPLETED   10   9 
NOT COMPLETED   2   2 
Lost to Follow-up                1                1 
Withdrawal by Subject                1                1 



  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.
No text entered.

Reporting Groups
  Description
Pioglitazone pioglitazone: pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
Placebo placebo: matching placebo (inert tablet)
Total Total of all reporting groups

Baseline Measures
   Pioglitazone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   11   23 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12 100.0%      11 100.0%      23 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.4  (10)   41  (14.1)   40.2  (12.05) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  58.3%      8  72.7%      15  65.2% 
Male      5  41.7%      3  27.3%      8  34.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4  33.3%      2  18.2%      6  26.1% 
White      8  66.7%      9  81.8%      17  73.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   12   11   23 
Age asthma onset 
[Units: Years]
Mean (Standard Deviation)
 15  (11)   21  (18.9)   18  (14.95) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 38.8  (6.8)   43.5  (7.8)   41.15  (7.3) 
Seasonal allergies 
[Units: Participants]
     
Reported allergies   10   10   20 
Non-allergic   2   1   3 
Gastroesophageal Reflux Disease (GERD) 
[Units: Participants]
     
Participants with GERD   7   5   12 
Participants without GERD   5   6   11 
Depression 
[Units: Participants]
     
Participants reporting Depression   7   6   13 
Participants without Depression   5   5   10 
Asthma exacerbation in last 12 months 
[Units: Participants]
     
Reported an exacerbation   6   7   13 
No reported exacerbation   6   4   10 
Oral steroids in last 12 months 
[Units: Participants]
     
Used oral steroids   7   4   11 
Did not use oral steroids   5   7   12 
Inhaled corticosteroid 
[Units: Participants]
     
High dose   4   5   9 
Medium dose   8   4   12 
Low dose   0   2   2 
Long acting beta agonist 
[Units: Participants]
     
Used long acting beta agonist   10   9   19 
Did not use long acting beta agonist   2   2   4 
Short acting beta agonist 
[Units: Participants]
     
Used short acting beta agonist   11   11   22 
Did not use short acting beta agonist   1   0   1 
Exhaled Nitric Oxide 
[Units: Ppb]
Mean (Standard Deviation)
 27.6  (27.8)   30.8  (28.4)   29.2  (28.1) 
Immunoglobulin E 
[Units: IU/ml]
Mean (Standard Deviation)
 291.2  (313.2)   575  (544.7)   433.1  (428.95) 
Juniper Asthma Control [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 1.75  (.63)   2.48  (1.3)   2.115  (.965) 
[1] Scale Range: minimum 1.0; maximum 6.0 Higher values represent increased asthma symptoms A score greater than 1.5 is considered compatible with uncontrolled asthma
FEV1 (% predicted before bronchodilator use) 
[Units: % predicted]
Mean (Standard Deviation)
 82.3  (12.1)   81.5  (15.2)   81.9  (13.65) 
FVC (% predicted before bronchodilator use) 
[Units: % predicted]
Mean (Standard Deviation)
 86.8  (13.7)   85.3  (16.2)   86.05  (14.95) 
FEV1/FVC (% predicted before bronchodilator use) 
[Units: % predicted]
Mean (Standard Deviation)
 95.3  (11.2)   94.9  (11.12)   95.1  (11.16) 
FEV1 (% predicted after bronchodilator use) 
[Units: % predicted]
Mean (Standard Deviation)
 77.3  (25.1)   88.1  (4.6)   82.7  (14.85) 
FVC (% predicted after bronchodilator use) 
[Units: % predicted]
Mean (Standard Deviation)
 79.5  (27.6)   88.3  (16.3)   83.9  (21.95) 
FEV1/FVC (% predicted after bronchodilator use) 
[Units: % predicted]
Mean (Standard Deviation)
 90.9  (31.2)   97.8  (7.82)   94.35  (19.51) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Airway Reactivity   [ Time Frame: 12 weeks ]

2.  Secondary:   FEV1 % Predicted   [ Time Frame: 12 weeks ]

3.  Secondary:   Juniper Asthma Control Questionnaire   [ Time Frame: 12 weeks ]

4.  Secondary:   Exhaled Nitric Oxide Ppb   [ Time Frame: 12 weeks ]


  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: Dr. Fernando Holguin
Organization: University of Pittsburgh
phone: 412-692-2817
e-mail: holguinf@upmc.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fernando Holguin, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00634036     History of Changes
Other Study ID Numbers: GLITZ 001
00001949
Study First Received: March 5, 2008
Results First Received: March 18, 2016
Last Updated: June 19, 2017