Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

NCT ID: NCT00879879

Last Updated: 2021-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Precancerous Condition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Losartan

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

Group Type EXPERIMENTAL

losartan

Intervention Type DRUG

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

Interventions

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losartan

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

Intervention Type DRUG

Other Intervention Names

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losartan potassium

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marisa Couluris, DO

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SCUSF-PILOT-0108

Identifier Type: OTHER

Identifier Source: secondary_id

5U10CA081920

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SCUSF 0108 Pilot

Identifier Type: -

Identifier Source: org_study_id

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