|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 Lead Organizations/Sponsors
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaNational Cancer Institute
|Marisa Couluris||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00879879
ClinicalTrials.gov processed this data on October 17, 2013
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