Trial Outcomes & Findings for Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis (NCT NCT00879879)

NCT ID: NCT00879879

Last Updated: 2021-02-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2021-02-21

Participant Flow

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

Participant milestones

Measure	Losartan 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 Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Losartan 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 Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Measure	Losartan n=20 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 6.24 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
FVC% Predicted	73.96 Percentage STANDARD_DEVIATION 3.76 • n=5 Participants
DLCO% Predicted	43.65 Percentage STANDARD_DEVIATION 16.91 • n=5 Participants
6MWT Distance	464.89 meters STANDARD_DEVIATION 249.54 • n=5 Participants
Chronic O2 Supplementation	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Patients who received losartan for 12 months

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.

Outcome measures

Measure	Losartan n=17 Participants 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
Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year Stable	7 Participants
Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year Improved	5 Participants
Number of Participants With Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year Deteriorated	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Patients who received losartan for 12 months.

Outcome measures

Measure	Losartan n=17 Participants 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
Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year Stable	10 Participants
Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year Improved	2 Participants
Number of Participants With Stable, Improved, or Deteriorated Diffusion Capacity of Carbon Monoxide (DLCO) at 1 Year Deteriorated	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Patients who received losartan for 12 months

Outcome measures

Measure	Losartan n=17 Participants 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
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year Stable	8 Participants
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year Improved	2 Participants
Number of Patients With Stable, Improved or Deteriorated Forced Expiratory Volume at 1 Second (%FEV1) at 1 Year Deteriorated	7 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Patients who received losartan for 12 months.

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.

Outcome measures

Measure	Losartan n=17 Participants 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
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year Stable	5 Participants
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year Improved	2 Participants
Number of Patients With Stable, Improved or Deteriorated Baseline/Transition Dyspnea Index at 1 Year Deteriorated	10 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Patients who received losartan for 12 months.

Outcome measures

Measure	Losartan n=17 Participants 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
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year Improved	5 Participants
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year Stable	6 Participants
Number of Patients With Stable, Improved or Deteriorated 6-minute Walk Test Results at 1 Year Deteriorated	6 Participants

Adverse Events

Losartan

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Losartan n=20 participants at risk 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
Immune system disorders Death due to disease progression	5.0% 1/20 • Number of events 1

Other adverse events

Measure	Losartan n=20 participants at risk 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
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Number of events 1
General disorders Fatigue	5.0% 1/20 • Number of events 1

Additional Information

Dr. Jeffrey Krischer, Principal Investigator

SunCoast CCOP Research Base

Phone: 813-396-9245

Email: ccop@epi.usf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place