Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

University of South Florida

Status: Completed

Conditions: Precancerous Condition

Treatments: Drug: losartan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00879879

SCUSF-PILOT-0108 (Other Identifier)

SCUSF 0108 Pilot

5U10CA081920 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Losartan

Experimental group

Description:

50 mg tablets of losartan taken daily by mouth for 1 year

Treatment:

Drug: losartan