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Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00879879
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Precancerous Condition Drug: losartan

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
Study Start Date : March 2009
Primary Completion Date : March 2012
Study Completion Date : March 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: Losartan
50 mg tablets of losartan taken daily by mouth for 1 year
Drug: losartan
50 mg losartan taken daily by mouth in capsule form for 1 year
Other Name: losartan potassium


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Diffusion Capacity of Carbon Monoxide (DLCO) [ Time Frame: 1 year ]
  2. Total Lung Capacity by Plethysmography [ Time Frame: 1 year ]
  3. Baseline/Transition Dyspnea Index [ Time Frame: 1 year ]
  4. 6-minute Walk Test Results [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879879


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Investigators
Principal Investigator: Marisa Couluris, DO University of South Florida
More Information

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00879879     History of Changes
Other Study ID Numbers: SCUSF 0108 Pilot
SCUSF-PILOT-0108 ( Other Identifier: SunCoast CCOP Research Base )
5U10CA081920 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2009    Key Record Dates
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013
Last Verified: August 2013

Keywords provided by University of South Florida:
precancerous condition

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Precancerous Conditions
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Neoplasms
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action