Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT00879879|
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
RATIONALE: Losartan may be effective in treating patients with idiopathic pulmonary fibrosis.
PURPOSE: This clinical trial is studying the side effects of losartan and to see how well it works in treating patients with idiopathic pulmonary fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Precancerous Condition||Drug: losartan||Not Applicable|
- Evaluate the effects of losartan potassium on disease progression in patients with idiopathic pulmonary fibrosis.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral losartan potassium daily for 1 year in the absence of disease progression or unacceptable toxicity.
Patients undergo pulmonary function tests with gas diffusion lung volumes, Carbon monoxide diffusing capacity (DLCO) tests, and 6-minute walk tests at baseline and then at 3, 6, 9, and 12 months. Patients also complete baseline/transition dyspnea index questionnaires at baseline and then at 1, 3, 6, 9, and 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
U.S. FDA Resources
50 mg tablets of losartan taken daily by mouth for 1 year
50 mg losartan taken daily by mouth in capsule form for 1 year
Other Name: losartan potassium
- Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year [ Time Frame: 1 year ]
Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline.
Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment.
- Diffusion Capacity of Carbon Monoxide (DLCO) [ Time Frame: 1 year ]
- Total Lung Capacity by Plethysmography [ Time Frame: 1 year ]
- Baseline/Transition Dyspnea Index [ Time Frame: 1 year ]
- 6-minute Walk Test Results [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879879
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Marisa Couluris, DO||University of South Florida|