Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT00879879
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Precancerous Condition	Drug: losartan	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Idiopathic Pulmonary Fibrosis With Losartan: A Pilot Project
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: losartan potassium

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year [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

1. Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year [1 year]

2. Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year [1 year]

3. Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year [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.

4. Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• University of South Florida
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Marisa Couluris, DO, University of South Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT00879879
• Other Study ID Numbers: SCUSF 0108 Pilot; SCUSF-PILOT-0108; 5U10CA081920
• First Posted: Apr 13, 2009
• Last Update Posted: Feb 21, 2021
• Last Verified: Sep 1, 2018

• Keywords provided by University of South Florida: precancerous condition
• Additional relevant MeSH terms: Precancerous Conditions; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Losartan

Study Results

Participant Flow

Recruitment Details	Subjects recruited from SunCoast Community Clinical Oncology Program (CCOP) Research Base affiliated CCOP members located in the United States.

Arm/Group Title	Losartan
Arm/Group Description	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
Period Title: Overall Study
STARTED	20
COMPLETED	17
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Losartan
Arm/Group Description	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
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 35%
>=65 years	13 65%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (6.24)
Sex: Female, Male (Count of Participants)
Female	5 25%
Male	15 75%
Region of Enrollment (participants) [Number]
United States	20 100%
FVC% Predicted (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	73.96 (3.76)
DLCO% Predicted (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	43.65 (16.91)
6MWT Distance (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	464.89 (249.54)
Chronic O2 Supplementation (Count of Participants)
Count of Participants [Participants]	9 45%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who received losartan for 12 months

Arm/Group Title	Losartan
Arm/Group Description	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
Measure Participants	17
Stable	7 35%
Improved	5 25%
Deteriorated	5 25%

2. Secondary Outcome

Title	Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Patients who received losartan for 12 months.

Arm/Group Title	Losartan
Arm/Group Description	50 mg tablets of losartan taken daily by mouth for 1 year
Measure Participants	17
Stable	10 50%
Improved	2 10%
Deteriorated	5 25%

3. Secondary Outcome

Title	Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Patients who received losartan for 12 months

Arm/Group Title	Losartan
Arm/Group Description	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
Measure Participants	17
Stable	8 40%
Improved	2 10%
Deteriorated	7 35%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who received losartan for 12 months.

Arm/Group Title	Losartan
Arm/Group Description	50 mg tablets of losartan taken daily by mouth for 1 year
Measure Participants	17
Stable	5 25%
Improved	2 10%
Deteriorated	10 50%

5. Secondary Outcome

Title	Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Patients who received losartan for 12 months.

Arm/Group Title	Losartan
Arm/Group Description	50 mg tablets of losartan taken daily by mouth for 1 year Change in secondary markers of lung function over 12 months of losartan therapy, N=17 N (%) Stable 6 (35.29) Improved 5 (29.41) Deteriorated 6 (-1.38)
Measure Participants	17
Stable	6 30%
Improved	5 25%
Deteriorated	6 30%

Adverse Events

Arm/Group Title	Losartan
Arm/Group Description	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
All Cause Mortality
	Losartan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Losartan
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Immune system disorders
Death due to disease progression	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	Losartan
	Affected / at Risk (%)	# Events
Total	2/20 (10%)
General disorders
Fatigue	1/20 (5%)	1
Skin and subcutaneous tissue disorders
Rash	1/20 (5%)	1

Limitations/Caveats

A future phase II study is necessary to establish losartan's effect on IPF, due to a small number of patients and lack of controls to establish statistically significant efficacy.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.