Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00879879
First received: April 10, 2009
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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 Intervention
Precancerous Condition
Drug: losartan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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:
  • Diffusion Capacity of Carbon Monoxide (DLCO) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Total Lung Capacity by Plethysmography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Baseline/Transition Dyspnea Index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 6-minute Walk Test Results [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879879

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Marisa Couluris, DO University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00879879     History of Changes
Other Study ID Numbers: SCUSF 0108 Pilot, SCUSF-PILOT-0108, 5U10CA081920
Study First Received: April 10, 2009
Results First Received: August 9, 2013
Last Updated: August 9, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of South Florida:
precancerous condition

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

ClinicalTrials.gov processed this record on April 17, 2014