Text Size

The Use of Rosiglitazone to Treat Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tammy Wichman, Creighton University
ClinicalTrials.gov Identifier:
NCT00614874
First received: January 31, 2008
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
Results First Received: June 17, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Intervention: Drug: rosiglitazone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was through pulmonary and allergy/immunology clinics from September 2008 to November 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
32 patients assessed for eligibility. 16 did not meet inclusion criteria. None of the 16 participants allocated to treatment were excluded before the study began.

Reporting Groups
  Description
Rosiglitazone Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks

Participant Flow:   Overall Study
    Rosiglitazone  
STARTED     16  
COMPLETED     14  
NOT COMPLETED     2  
Protocol Violation                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Rosiglitazone Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks

Baseline Measures
    Rosiglitazone  
Number of Participants  
[units: participants]
 		  16  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  34  ± 24  
Gender  
[units: participants]
 		 
Female     10  
Male     6  
Region of Enrollment  
[units: participants]
 		 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Methacholine Responsiveness as Assessed by PC20,   [ Time Frame: patients were assessed at baseline and at 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion   [ Time Frame: patients were assessed at baseline and 12 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: patients were assessed at baseline and 12 weeks ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Forced Expiratory Volume in 1 Second (FEV1)
Measure Description FEV1 in liters
Time Frame patients were assessed at baseline and 12 weeks  
Safety Issue No  

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.
Two subjects withdrew from the study in visit 3

Reporting Groups
  Description
Rosiglitazone Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks

Measured Values
    Rosiglitazone  
Number of Participants Analyzed  
[units: participants]
 		  14  
Forced Expiratory Volume in 1 Second (FEV1)  
[units: Liters]
Mean ± Standard Deviation 		 
Baseline     2.95  ± 0.89  
Week 12     3.04  ± 0.95  


Statistical Analysis 1 for Forced Expiratory Volume in 1 Second (FEV1)
Groups [1] Rosiglitazone
Method [2] Friedman
P Value [3] 0.398
Mean Difference (Final Values) [4] 0.09
Standard Deviation ± 0.95
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Comparison was at baseline and week 12
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Forced Expiratory Volume in One Second (FEV1) Percent Predicted   [ Time Frame: patients were assessed at baseline and 12 weeks ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
Small sample size. Lack of placebo control arm.  


Results Point of Contact:  
Name/Title: Dr. Tammy Wichman
Organization: Creighton University School of Medicine
phone: 402-449-4486
e-mail: wichman@creighton.edu


Publications:


Responsible Party: Tammy Wichman, Creighton University
ClinicalTrials.gov Identifier: NCT00614874     History of Changes
Other Study ID Numbers: 07-14592
Study First Received: January 31, 2008
Results First Received: June 17, 2011
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board