Trial Outcomes & Findings for Effectiveness of Triple Therapy in COPD (NCT NCT03724877)

Results Overview

The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with a primary diagnosis of COPD (severe exacerbation) is presented.

Recruitment status

COMPLETED

Target enrollment

8853 participants

Primary outcome timeframe

1 year

Results posted on

2019-12-03

Participant Flow

Base cohort consisted participants with ChronicObstructivePulmonaryDisease(COPD) who subsequently received at least one prescription for a long-acting bronchodilator, either Long-Acting Beta2-Agonist(LABA) or long-acting MuscarinicAntagonists(LAMA), or for inhaled corticosteroid(ICS), alone or in combination, from 1January2002 until 31December2015.

Population-based incident new-user cohort design with high-dimensional time-conditional propensity score matching. The study cohort was formed from the base cohort using an incident new-user cohort design with time-conditional propensity scores.

Participant milestones

Participant milestones
Measure	LABA-LAMA-ICS The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.	LABA-LAMA The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
Overall Study STARTED	6921	1932
Overall Study COMPLETED	6921	1932
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LABA-LAMA-ICS n=6921 Participants The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.	LABA-LAMA n=1932 Participants The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.	Total n=8853 Participants Total of all reporting groups
Age, Continuous	71.9 Years STANDARD_DEVIATION 8.5 • n=6921 Participants	71.6 Years STANDARD_DEVIATION 8.5 • n=1932 Participants	71.8 Years STANDARD_DEVIATION 8.5 • n=8853 Participants
Sex: Female, Male Female	2619 Participants n=6921 Participants	746 Participants n=1932 Participants	3365 Participants n=8853 Participants
Sex: Female, Male Male	4302 Participants n=6921 Participants	1186 Participants n=1932 Participants	5488 Participants n=8853 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1 year

Population: The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.

The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with a primary diagnosis of COPD (severe exacerbation) is presented.

Outcome measures

Outcome measures
Measure	LABA-LAMA-ICS n=6921 Participants The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.	LABA-LAMA n=1932 Participants The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
Number of Participants Hospitalised With Severe Exacerbation	3074 Participants	630 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.

The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) is presented.

Outcome measures

Outcome measures
Measure	LABA-LAMA-ICS n=6921 Participants The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.	LABA-LAMA n=1932 Participants The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
Number of Participants Hospitalised With Moderate Exacerbation	2487 Participants	542 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.

The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).

Outcome measures

Outcome measures
Measure	LABA-LAMA-ICS n=6921 Participants The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.	LABA-LAMA n=1932 Participants The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)	3099 Participants	634 Participants

SECONDARY outcome

Timeframe: 1 year

Population: The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.

This outcome was based on the number of hospitalizations and on the number of courses of treatment with an oral corticosteroid. A gap of at least 30 days between treatment courses was required to consider the exacerbations as separate events.

Outcome measures

Outcome measures
Measure	LABA-LAMA-ICS n=6921 Participants The participants with COPD initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day were included in this group. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.	LABA-LAMA n=1932 Participants The participants with COPD with their first concurrent prescriptions of a LAMA and LABA (no ICS) as two inhalers on the same day included in this group were matched on high-dimensional propensity score with patients initiating treatment with LABA-LAMA-ICS combination as three or two inhalers on the same day. Participants were followed for up to one year from the cohort entry date, the date of death, 31 March 2016, or the end of coverage in the practice, whichever occurred first.
The Rate of COPD Exacerbations Over the One-year Follow-up Moderate/ sever exacerbation	94.4 exacerbations per 100 person year	89.3 exacerbations per 100 person year
The Rate of COPD Exacerbations Over the One-year Follow-up Severe exacerbation	13.4 exacerbations per 100 person year	11.0 exacerbations per 100 person year

Adverse Events

LABA-LAMA-ICS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LABA-LAMA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER