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OpenTrials
Completed

NCT Number: NCT00879879

Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan

Drug

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

Other names: losartan potassium

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 1 year

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

    Time frame: 1 year

  3. 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.

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2009
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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