Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
Information source: University of South Florida
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Precancerous Condition
Intervention: losartan (Drug)
Phase: N/A
Status: Completed
Sponsored by: 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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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, Carbon monoxide
diffusing capacity (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:
INCLUSION CRITERIA:
- Age > 21 years
- Diagnosis of idiopathic pulmonary fibrosis
- Patients taking Coumadin and/or N-acetylcysteine may participate in the study
- Baseline forced vital capacity (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
Locations and Contacts
University of Cincinnati, Cincinnati, Ohio 45267, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2009
Last updated: August 9, 2013
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