Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
21 Years
N/A
Both
Precancerous Condition
Trial Information
Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
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.
Inclusion Criteria
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
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
Type of Study:
Interventional
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:
No
Principal Investigator
Marisa Couluris, DO
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of South Florida
Authority:
United States: Data and Safety Monitoring Board
Study ID:
SCUSF 0108 Pilot
NCT ID:
NCT00879879
Start Date:
March 2009
Completion Date:
Related Keywords:
- Precancerous Condition
- precancerous condition
- Fibrosis
- Precancerous Conditions
- Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
Name | Location |
|---|---|
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
