Full Text View
Tabular View
No Study Results Posted
Related Studies
Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: April 10, 2009   Last Updated: January 27, 2010   History of Changes
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00879879
  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 potassium

Study Type: Interventional
Study Design: Treatment
Official Title: Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Stable or improved forced vital capacity (FVC) response at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diffusion capacity of carbon monoxide (DLCO) [ Designated as safety issue: No ]
  • Total lung capacity by plethysmography [ Designated as safety issue: No ]
  • Baseline/transition dyspnea index [ Designated as safety issue: No ]
  • 6-minute walk test results [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: March 2009
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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, 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

DISEASE CHARACTERISTICS:

  • Diagnosis of idiopathic pulmonary fibrosis as indicated by 1 of the following:

    • Histologically confirmed usual interstitial pneumonia on surgical lung biopsy
    • Abnormal pulmonary function studies that include the following:

      • Evidence of a restrictive pattern or impaired gas exchange
      • Bibasilar reticular abnormalities with minimal ground glass opacities on high-resolution CT scans
      • Transbronchial lung biopsy or bronchoalveolar lavage showing no features to support an alternative diagnosis
  • All other known causes of interstitial lung disease ruled out AND meets ≥ 3 of the following minor criteria:

    • Age > 50 years
    • Insidious onset of otherwise unexplained dyspnea on exertion
    • Duration of illness ≥ 3 months
    • Bibasilar, inspiratory crackles
  • Baseline forced vital capacity (FVC) ≥ 50%
  • Able to walk ≥ 200 meters without requiring > 6 liters of oxygen per minute as documented by baseline 6-minute walk test

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to attend clinic visits
  • Baseline systolic blood pressure ≥ 100 mm Hg
  • No cigarette or marijuana smoking within the past 6 months
  • No history of kidney failure or liver disease
  • No allergy or allergic reaction to losartan potassium or any other angiotensin II receptor blocker

PRIOR CONCURRENT THERAPY:

  • No prior lung transplant
  • More than 1 month since prior and no concurrent immunosuppressant agents (e.g., azathioprine, cyclophosphamide, colchicine, and/or prednisone)
  • No other concurrent angiotensin II receptor blocker
  • Concurrent coumadin and/or N-acetylcysteine allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879879

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Brent Kinder, MD     513-558-0191        
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Marisa Couluris, DO University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center CCOP Research Base ( Viki Huegel )
Study ID Numbers: CDR0000637800, MCC-PILOT-0108
Study First Received: April 10, 2009
Last Updated: January 27, 2010
ClinicalTrials.gov Identifier: NCT00879879     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
precancerous condition

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

ClinicalTrials.gov processed this record on February 08, 2010