An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 1 site in United Kingdom. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Boehringer Ingelheim · Observational
To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 8,853 is above the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Incident new-user cohort design with high-dimensional propensity scores to match the two comparison groups of COPD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS) · Drug: Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)
(LABA-LAMA-ICS)
(LABA-LAMA)
Number of Participants Hospitalised With Severe Exacerbation
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.
Time frame: 1 year
Number of Participants Hospitalised With Moderate Exacerbation
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.
Time frame: 1 year
Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)
The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).
Time frame: 1 year
The Rate of COPD Exacerbations Over the One-year Follow-up
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.
Time frame: 1 year
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.
| Milestone | LABA-LAMA-ICS | LABA-LAMA |
|---|---|---|
| Started | 6921 | 1932 |
| Completed | 6921 | 1932 |
| Not completed | 0 | 0 |
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.
| Participants | LABA-LAMA-ICS | LABA-LAMA |
|---|---|---|
| Number of Participants Hospitalised With Severe Exacerbation | 3074 | 630 |
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.
| Participants | LABA-LAMA-ICS | LABA-LAMA |
|---|---|---|
| Number of Participants Hospitalised With Moderate Exacerbation | 2487 | 542 |
The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).
| Participants | LABA-LAMA-ICS | LABA-LAMA |
|---|---|---|
| Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia) | 3099 | 634 |
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.
| exacerbations per 100 person year | LABA-LAMA-ICS | LABA-LAMA |
|---|---|---|
| Moderate/ sever exacerbation | 94.4 | 89.3 |
| Severe exacerbation | 13.4 | 11.0 |
Collected over Adverse event information was not applicable for this study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LABA-LAMA-ICS | — | — | — |
| LABA-LAMA | — | — | — |
The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.
| Age, Continuous(Years) | LABA-LAMA-ICS | LABA-LAMA | Total |
|---|---|---|---|
| Mean | 71.9 ± 8.5 | 71.6 ± 8.5 | 71.8 ± 8.5 |
| Sex: Female, Male(Participants) | LABA-LAMA-ICS | LABA-LAMA | Total |
|---|---|---|---|
| Female | 2619 | 746 | 3365 |
| Male | 4302 | 1186 | 5488 |
| Race and Ethnicity Not Collected(Participants) | LABA-LAMA-ICS | LABA-LAMA | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to: find information in order to request access to clinical study data, for listed studies. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.
Ran from Nov 2018 to primary completion in Nov 2018, 0 months.
Results were first posted in Dec 2019, 1 year after primary completion.
Of 99 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 0 months is below that.
Counting every sponsor, half of 429 studies reached it within 28 months; a quarter within 16 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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