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Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Primary Purpose

Precancerous Condition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
losartan
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precancerous Condition focused on measuring precancerous condition

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Losartan

Arm Description

50 mg tablets of losartan taken daily by mouth for 1 year

Outcomes

Primary Outcome Measures

Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 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.

Secondary Outcome Measures

Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 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.
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year

Full Information

First Posted
April 10, 2009
Last Updated
February 18, 2021
Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00879879
Brief Title
Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis
Official Title
Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Condition
Keywords
precancerous condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Experimental
Arm Description
50 mg tablets of losartan taken daily by mouth for 1 year
Intervention Type
Drug
Intervention Name(s)
losartan
Other Intervention Name(s)
losartan potassium
Intervention Description
50 mg losartan taken daily by mouth in capsule form for 1 year
Primary Outcome Measure Information:
Title
Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year
Time Frame
1 year
Title
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
Time Frame
1 year
Title
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year
Description
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.
Time Frame
1 year
Title
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa Couluris, DO
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

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Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

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