- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00879879
Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
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.
Study Overview
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, 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan
50 mg tablets of losartan taken daily by mouth for 1 year
|
50 mg losartan taken daily by mouth in capsule form for 1 year
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year
Time Frame: 1 year
|
Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline. Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment. |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year
Time Frame: 1 year
|
1 year
|
|
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
Time Frame: 1 year
|
1 year
|
|
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year
Time Frame: 1 year
|
This index measures a patient's degree of breathlessness related to their activities of daily living including their functional impairment and their magnitude of task and effort.
|
1 year
|
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCUSF 0108 Pilot
- SCUSF-PILOT-0108 (Other Identifier: SunCoast CCOP Research Base)
- 5U10CA081920 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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