Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Precancerous Condition
• Interventions: Drug: losartan

• Registration Number: NCT00879879
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-08-09
• Results First Submitted QC: 2013-08-09
• Results First Posted: 2013-10-14
• Status Verified: 2018-09
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Losartan	losartan	50 mg tablets of losartan taken daily by mouth for 1 year

Primary Outcome Measures

Name	Time	Method
Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year	1 year
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year	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.
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

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States