Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
Basic Trial Information
|No phase specified||Treatment||Completed||21 and over||NCI, Other||SCUSF 0108 Pilot|
SCUSF-PILOT-0108, 5U10CA081920, MCC-PILOT-0108, PILOT 0108, NCT00879879
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.
Further Study Information
- 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.
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- National Cancer Institute
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00879879
ClinicalTrials.gov processed this data on October 20, 2014
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.