Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Active	21 and over	NCI	MCC-PILOT-0108 PILOT 0108, NCT00879879

Objectives

1. Evaluate the effects of losartan potassium on disease progression in patients with idiopathic pulmonary fibrosis.
2. Determine the safety of this drug in these patients.

Entry 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

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

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

Expected Enrollment

Outcomes

Stable or improved forced vital capacity (FVC) response at 1 year

Diffusion capacity of carbon monoxide (DLCO)
Total lung capacity by plethysmography
Baseline/transition dyspnea index
6-minute walk test results

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Marisa Couluris, DO, Principal investigator		Ph: 813-396-9547

U.S.A.
Ohio
	Cincinnati
	University of Cincinnati
		Brent Kinder, MD	Ph:  513-558-0191

Registry Information
Official Title		Treatment of Idiopathic Pulmonary Fibrosis with Losartan: A Pilot Project
Trial Start Date		2009-03-09
Trial Completion Date		2012-03-09 (estimated)
Registered in ClinicalTrials.gov		NCT00879879
Date Submitted to PDQ		2009-03-11
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA76292

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