Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project|
- Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Total Lung Capacity by Plethysmography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Baseline/Transition Dyspnea Index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 6-minute Walk Test Results [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
- 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.
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Marisa Couluris, DO||University of South Florida|