Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
OBJECTIVES: 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.

Official Title
-----------------
Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

Conditions
-----------------
Precancerous Condition

Intervention / Treatment
-----------------
* Drug: losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Age > 21 years Diagnosis of idiopathic pulmonary fibrosis Patients taking Coumadin and/or N-acetylcysteine may participate in the study Baseline forced vital capacity (FVC) must be greater than or equal to 50% Baseline 6 minute walk test distance walked must be greater than or equal to 200 meters not requiring greater than 6 lpm of oxygen EXCLUSION CRITERIA: Pregnant, intending to become pregnant or breastfeeding Current or previous smoker of cigarettes or marijuana that recently quit within the last 6 months prior to enrollment Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker Taking losartan or any other angiotensin II receptor blocker Baseline systolic blood pressure < 100 mmHg Currently taking or has taken immunosuppressant agents within the last month such as azathioprine, cyclophosphamide, colchicine and/or prednisone History of lung transplant History of kidney failure or liver disease Inability to attend clinic visits

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan<br>50 mg tablets of losartan taken daily by mouth for 1 year | Drug: losartan<br>* 50 mg losartan taken daily by mouth in capsule form for 1 year<br>* Other names: losartan potassium;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year |  | 1 year | 
| Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year |  | 1 year | 
| Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year | This index measures a patient's degree of breathlessness related to their activities of daily living including their functional impairment and their magnitude of task and effort. | 1 year | 
| Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
precancerous condition