Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

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, 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.

DISEASE CHARACTERISTICS:

- Diagnosis of idiopathic pulmonary fibrosis as indicated by 1 of the following:

- Histologically confirmed usual interstitial pneumonia on surgical lung biopsy

- Abnormal pulmonary function studies that include the following:

- Evidence of a restrictive pattern or impaired gas exchange

- Bibasilar reticular abnormalities with minimal ground glass opacities on
high-resolution CT scans

- Transbronchial lung biopsy or bronchoalveolar lavage showing no features to
support an alternative diagnosis

- All other known causes of interstitial lung disease ruled out AND meets ≥ 3 of the
following minor criteria:

- Age > 50 years

- Insidious onset of otherwise unexplained dyspnea on exertion

- Duration of illness ≥ 3 months

- Bibasilar, inspiratory crackles

- Baseline forced vital capacity (FVC) ≥ 50%

- Able to walk ≥ 200 meters without requiring > 6 liters of oxygen per minute as
documented by baseline 6-minute walk test

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to attend clinic visits

- Baseline systolic blood pressure ≥ 100 mm Hg

- No cigarette or marijuana smoking within the past 6 months

- No history of kidney failure or liver disease

- No allergy or allergic reaction to losartan potassium or any other angiotensin II
receptor blocker

PRIOR CONCURRENT THERAPY:

- No prior lung transplant

- More than 1 month since prior and no concurrent immunosuppressant agents (e.g.,
azathioprine, cyclophosphamide, colchicine, and/or prednisone)

- No other concurrent angiotensin II receptor blocker

- Concurrent coumadin and/or N-acetylcysteine allowed