An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 1 site in Canada. Open to participants aged Up to 55 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Boehringer Ingelheim · Observational
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Among 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim — 1 open to participants now, 1 under way, 1 of them phase 3. Pulmonary Disease, Chronic Obstructive · Boehringer Ingelheim.
Among the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim, this one is the 28th largest by enrollment of the 80 observational ones that give a count, is one of 9 that started in 2017, is one of 81 observational ones, and was the 207th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →1 of the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim is open now, in 3 countries. Recruiting first, the newest first:
Boehringer Ingelheim · Sites in United States, Italy, Malaysia
Ages 40+
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: Up to 55 Years · all sexes · no healthy volunteers.
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236 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 9 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,954 is above the median of 159 across 1,498 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 166 across the 155 interventional studies, 1,577 across the 80 observational. Of the 232 that completed or were terminated, 124 (53%) have results posted.
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Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.
The base cohort will consist of all patients with a diagnosis of COPD from 1 January 1995 until 31 December 2015 who subsequently received at least one prescription for a long-acting bronchodilator, either LABA or tiotropium, or for an inhaled corticosteroid, alone or in combination, from 1 January 2002 until 31 December 2015.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease
Drug: LABA and the LAMA tiotropium (LABA-TIO) · Drug: LABA and an ICS (LABA-ICS)
combinational drug
Also known as: FORVENT, SPIRIVA, SRIVASSO
combinational drug
The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry
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.
Time frame: 12 Years
The Rate of COPD Exacerbations
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.
Time frame: 12 years
The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)
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.
Time frame: 12 years
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.
| Milestone | LABA-ICS | LABA-TIO |
|---|---|---|
| Started | 1977 | 1977 |
| Completed | 1977 | 1977 |
| Not completed | 0 | 0 |
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.
| Participants | LABA-ICS | LABA-TIO |
|---|---|---|
| Moderate/severe exacerbation | 344 | 412 |
| Severe exacerbation | 55 | 60 |
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.
| Events per participant-year | LABA-ICS | LABA-TIO |
|---|---|---|
| Moderate/severe exacerbation | 0.83 | 0.91 |
| Severe exacerbation | 0.13 | 0.11 |
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.
| Hospitalizations | LABA-ICS | LABA-TIO |
|---|---|---|
| As-treated analysis | 41 | 32 |
| On-treatment exposure | 143 | 49 |
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-ICS | — | — | — |
| LABA-TIO | — | — | — |
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. Baseline measures were presented for matched populations.
| Age, Continuous(Years) | LABA-ICS | LABA-TIO | Total |
|---|---|---|---|
| Mean | 71.8 ± 8.6 | 71.9 ± 8.5 | 71.85 ± 8.55 |
| Sex: Female, Male(Participants) | LABA-ICS | LABA-TIO | Total |
|---|---|---|---|
| Female | 778 | 778 | 1556 |
| Male | 1199 | 1199 | 2398 |
| Race and Ethnicity Not Collected(Participants) | LABA-ICS | LABA-TIO | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Dec 2017, 0 months.
Results were first posted in Jul 2019, 1 year 6 months after primary completion.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →