Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

February 18, 2021 updated by: University of South Florida

Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Losartan
50 mg tablets of losartan taken daily by mouth for 1 year
50 mg losartan taken daily by mouth in capsule form for 1 year
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
Time Frame: 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
Time Frame: 1 year
1 year
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
Time Frame: 1 year
1 year
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year
Time Frame: 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
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

September 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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