Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Precancerous Condition
Intervention: losartan potassium (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: SunCoast CCOP Research Base at the University of South Florida Official(s) and/or principal investigator(s):
Marisa Couluris, DO, Principal Investigator, Affiliation: University of South Florida
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.
Clinical Details
Official title: Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
Study design: Primary Purpose: Treatment
Primary outcome: Stable or improved forced vital capacity (FVC) response at 1 year
Secondary outcome: Diffusion capacity of carbon monoxide (DLCO)Total lung capacity by plethysmography Baseline/transition dyspnea index 6-minute walk test results
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
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Brent Kinder, MD, Phone: 513-558-0191
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2009
Last updated: September 18, 2010
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