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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00879879 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Precancerous Condition |
Drug: losartan potassium |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of idiopathic pulmonary fibrosis as indicated by 1 of the following:
Abnormal pulmonary function studies that include the following:
All other known causes of interstitial lung disease ruled out AND meets ≥ 3 of the following minor criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Brent Kinder, MD 513-558-0191 | |
| Principal Investigator: | Marisa Couluris, DO | University of South Florida |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center CCOP Research Base ( Viki Huegel ) |
| Study ID Numbers: | CDR0000637800, MCC-PILOT-0108 |
| Study First Received: | April 10, 2009 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00879879 History of Changes |
| Health Authority: | Unspecified |
|
precancerous condition |
|
Lung Diseases, Interstitial Losartan Molecular Mechanisms of Pharmacological Action Precancerous Conditions Cardiovascular Agents Antihypertensive Agents Pulmonary Fibrosis |
Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Neoplasms Respiratory Tract Diseases Lung Diseases Therapeutic Uses Anti-Arrhythmia Agents |