Trial Outcomes & Findings for Comparative Effectiveness of COPD Treatments (NCT NCT03376295)

Results Overview

The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.

Recruitment status

COMPLETED

Target enrollment

3954 participants

Primary outcome timeframe

12 Years

Results posted on

2019-07-24

Participant Flow

Primary objective was to assess the effectiveness of maintenance treatment of ChronicObstructivePulmonaryDisease (COPD) with combination of Long-acting beta2-agonist(LABA) and the long-acting muscarinic antagonists(LAMA)tiotropium(TIO) compared with the combination of a LABA and an Inhaled corticosteroids(ICS) on the time to COPD exacerbation.

Population-based propensity score-matched incident new-user cohort study.

Participant milestones

Participant milestones
Measure	LABA-ICS The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.	LABA-TIO The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
Overall Study STARTED	1977	1977
Overall Study COMPLETED	1977	1977
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-ICS n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.	LABA-TIO n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.	Total n=3954 Participants Total of all reporting groups
Age, Continuous	71.8 Years STANDARD_DEVIATION 8.6 • n=1977 Participants	71.9 Years STANDARD_DEVIATION 8.5 • n=1977 Participants	71.85 Years STANDARD_DEVIATION 8.55 • n=3954 Participants
Sex: Female, Male Female	778 Participants n=1977 Participants	778 Participants n=1977 Participants	1556 Participants n=3954 Participants
Sex: Female, Male Male	1199 Participants n=1977 Participants	1199 Participants n=1977 Participants	2398 Participants n=3954 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 Years

Population: The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.

The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.

Outcome measures

Outcome measures
Measure	LABA-ICS n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.	LABA-TIO n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry Moderate/severe exacerbation	344 Participants	412 Participants
The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry Severe exacerbation	55 Participants	60 Participants

SECONDARY outcome

Timeframe: 12 years

Population: The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.

Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.

Outcome measures

Outcome measures
Measure	LABA-ICS n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.	LABA-TIO n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
The Rate of COPD Exacerbations Severe exacerbation	0.13 Events per participant-year	0.11 Events per participant-year
The Rate of COPD Exacerbations Moderate/severe exacerbation	0.83 Events per participant-year	0.91 Events per participant-year

SECONDARY outcome

Timeframe: 12 years

Population: The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.

The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.

Outcome measures

Outcome measures
Measure	LABA-ICS n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and an Inhaled corticosteroids (ICS) (LABA - ICS) prescription on the same day, during follow up. These patients were matched to patients receiving a LABA and a tiotropium on the same day (LABA-TIO) using a time-conditional propensity score-matched approach.	LABA-TIO n=1977 Participants The patients with COPD who received a Long-acting beta 2-agonist (LABA) and tiotropium (TIO) (LABA -TIO) prescription on the same day but no ICS, during follow up. These patients were matched to patients receiving a LABA and an ICS on the same day (LABA-ICS) using a time-conditional propensity score-matched approach.
The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) As-treated analysis	41 Hospitalizations	32 Hospitalizations
The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) On-treatment exposure	143 Hospitalizations	49 Hospitalizations

Adverse Events

LABA-ICS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LABA-TIO

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