Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

University of South Florida20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Precancerous Condition

Interventions

losartanDRUG

50 mg losartan taken daily by mouth in capsule form for 1 year

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year

Time frame: 1 year

Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year

Time frame: 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.

Time frame: 1 year

Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year

Time frame: 1 year

Data from ClinicalTrials.gov

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