Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT00879879
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2009-03-31
2012-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Losartan
50 mg tablets of losartan taken daily by mouth for 1 year
losartan
50 mg losartan taken daily by mouth in capsule form for 1 year
Interventions
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losartan
50 mg losartan taken daily by mouth in capsule form for 1 year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Marisa Couluris, DO
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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SCUSF-PILOT-0108
Identifier Type: OTHER
Identifier Source: secondary_id
SCUSF 0108 Pilot
Identifier Type: -
Identifier Source: org_study_id
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