Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
This study has been completed.
Sponsor:
University of South Florida
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00879879
First received: April 10, 2009
Last updated: May 21, 2013
Last verified: September 2010
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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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project |
Resource links provided by NLM:
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- Stable or improved forced vital capacity (FVC) response at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Diffusion capacity of carbon monoxide (DLCO) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Total lung capacity by plethysmography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Baseline/transition dyspnea index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 6-minute walk test results [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | March 2009 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Losartan
50 mg tablets of losartan taken daily by mouth for 1 year
|
Drug: losartan
50 mg losartan taken daily by mouth in capsule form for 1 year
Other Name: losartan potassium
|
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, 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 |
Criteria
INCLUSION CRITERIA:
- Age > 21 years
- Diagnosis of idiopathic pulmonary fibrosis
- Patients taking Coumadin and/or N-acetylcysteine may participate in the study
- Baseline 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879879
Locations
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
Sponsors and Collaborators
University of South Florida
Investigators
| Principal Investigator: | Marisa Couluris, DO | University of South Florida |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00879879 History of Changes |
| Other Study ID Numbers: | SCUSF 0108 Pilot, SCUSF-PILOT-0108 |
| Study First Received: | April 10, 2009 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
precancerous condition |
Additional relevant MeSH terms:
|
Fibrosis Precancerous Conditions Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Pathologic Processes Neoplasms Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |
Losartan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013