Trial Outcomes & Findings for Efficacy of Losartan in Preventing Progression of COPD (NCT NCT00720226)

NCT ID: NCT00720226

Last Updated: 2017-04-25

Results Overview

Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 106 participants
• Primary outcome timeframe: Change between baseline and month 12.
• Results posted on: 2017-04-25

Participant Flow

Participant milestones

Measure	Losartan Losartan 100 mg daily Losartan: Losartan 100 mg daily	Placebo Placebo 1 pill daily Placebo: Placebo pill daily
Overall Study STARTED	54	52
Overall Study COMPLETED	47	48
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Measure	Losartan Losartan 100 mg daily Losartan: Losartan 100 mg daily	Placebo Placebo 1 pill daily Placebo: Placebo pill daily
Overall Study Withdrawal by Subject	7	4

Baseline Characteristics

Participants with analyzable data pre-bronchodilator

Baseline characteristics by cohort

Measure	Losartan n=54 Participants Losartan 100 mg daily	Placebo n=52 Participants Placebo 1 tablet daily	Total n=106 Participants Total of all reporting groups
Age, Continuous	58.3 Years STANDARD_DEVIATION 10.0 • n=54 Participants	59.3 Years STANDARD_DEVIATION 9.8 • n=52 Participants	58.8 Years STANDARD_DEVIATION 14.0 • n=106 Participants
Sex: Female, Male Female	28 Participants n=54 Participants	25 Participants n=52 Participants	53 Participants n=106 Participants
Sex: Female, Male Male	26 Participants n=54 Participants	27 Participants n=52 Participants	53 Participants n=106 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=52 Participants	0 Participants n=106 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants	0 Participants n=52 Participants	0 Participants n=106 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=52 Participants	0 Participants n=106 Participants
Race (NIH/OMB) Black or African American	16 Participants n=54 Participants	14 Participants n=52 Participants	30 Participants n=106 Participants
Race (NIH/OMB) White	38 Participants n=54 Participants	38 Participants n=52 Participants	76 Participants n=106 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants	0 Participants n=52 Participants	0 Participants n=106 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants	0 Participants n=52 Participants	0 Participants n=106 Participants
FEV1 (L)	1.57 L (BTPS) STANDARD_DEVIATION 0.52 • n=51 Participants • Participants with analyzable data pre-bronchodilator	1.42 L (BTPS) STANDARD_DEVIATION .46 • n=51 Participants • Participants with analyzable data pre-bronchodilator	1.49 L (BTPS) STANDARD_DEVIATION 0.69 • n=102 Participants • Participants with analyzable data pre-bronchodilator
FEV1/FVC (%)	52.9 percent STANDARD_DEVIATION 10.5 • n=51 Participants • Participants with analyzable data from pre-bronchodilator spirometry	49.9 percent STANDARD_DEVIATION 11.3 • n=51 Participants • Participants with analyzable data from pre-bronchodilator spirometry	51.4 percent STANDARD_DEVIATION 15.4 • n=102 Participants • Participants with analyzable data from pre-bronchodilator spirometry
Smoking Status Current Smoker	36 participants n=54 Participants	36 participants n=52 Participants	72 participants n=106 Participants
Smoking Status Former Smoker	18 participants n=54 Participants	16 participants n=52 Participants	34 participants n=106 Participants
Emphysema on HRCT	24 Participants n=54 Participants	21 Participants n=52 Participants	45 Participants n=106 Participants

PRIMARY outcome

Timeframe: Change between baseline and month 12.

Population: Participants with 5-35% emphysema on baseline CT scan

Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.

Outcome measures

Measure	Losartan n=23 Participants Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)	Placebo n=20 Participants Placebo: Placebo pill daily (Participants with 5-35% emphysema)
Change in Percent Emphysema on CT Scan	-0.32 % Emphysema Whole Lung Standard Deviation 3.7	2.18 % Emphysema Whole Lung Standard Deviation 4.9

SECONDARY outcome

Timeframe: Measured at Baseline and Month 12

Population: Participants with 5-35% emphysema at baseline who had HRCT scans performed both at baseline and at 12 months.

Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.

Outcome measures

Measure	Losartan n=23 Participants Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)	Placebo n=20 Participants Placebo: Placebo pill daily (Participants with 5-35% emphysema)
Change in FEV1 (L)	-0.0879 L (BTPS) Standard Deviation 0.163	-0.0581 L (BTPS) Standard Deviation 0.167

Adverse Events

Losartan 100 mg Daily

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 18 serious events

Other events: 24 other events

Deaths: 1 deaths

Serious adverse events

Measure	Losartan 100 mg Daily n=54 participants at risk Losartan 100 mg daily Losartan: Losartan 100 mg daily	Placebo n=52 participants at risk Placebo 1 pill daily Placebo: Placebo pill daily
Respiratory, thoracic and mediastinal disorders COPD exacerbation	13.0% 7/54 • Number of events 7 • 1 year	34.6% 18/52 • Number of events 18 • 1 year

Other adverse events

Measure	Losartan 100 mg Daily n=54 participants at risk Losartan 100 mg daily Losartan: Losartan 100 mg daily	Placebo n=52 participants at risk Placebo 1 pill daily Placebo: Placebo pill daily
Respiratory, thoracic and mediastinal disorders Worsening of respiratory symptoms	35.2% 19/54 • Number of events 19 • 1 year	46.2% 24/52 • Number of events 24 • 1 year
Gastrointestinal disorders Worsening of gastrointestinal symptoms	13.0% 7/54 • Number of events 7 • 1 year	21.2% 11/52 • Number of events 11 • 1 year
Musculoskeletal and connective tissue disorders Worsening of musculoskeletal symptoms or fracture	14.8% 8/54 • Number of events 8 • 1 year	5.8% 3/52 • Number of events 3 • 1 year

Additional Information

Robert A. Wise

Johns Hopkins University School of Medicine

Phone: 410 550 0545

Email: rwise@jhmi.edu

Results disclosure agreements

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