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Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project

21 Years
Not Enrolling
Precancerous Condition

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Trial Information

Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project


- 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

Inclusion Criteria


- Age > 21 years

- Diagnosis of idiopathic pulmonary fibrosis

- Patients taking Coumadin and/or N-acetylcysteine may participate in the study

- Baseline 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Marisa Couluris, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida


United States: Data and Safety Monitoring Board

Study ID:

SCUSF 0108 Pilot



Start Date:

March 2009

Completion Date:

Related Keywords:

  • Precancerous Condition
  • precancerous condition
  • Fibrosis
  • Precancerous Conditions
  • Pulmonary Fibrosis
  • Idiopathic Pulmonary Fibrosis



University of CincinnatiCincinnati, Ohio  45267-0502