LABA-LAMA-ICS vs LABA-LAMA: Number of Participants Hospitalised With Severe Exacerbation
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.444 | 0.432 | 0.456 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.326 | 0.306 | 0.347 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.118 | 0.0938 | 0.142 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.36 | 1.27 | 1.46 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.65 | 1.48 | 1.84 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on LABA-LAMA-ICS than on LABA-LAMA | 8.47 | 7.06 | 10.7 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | 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. | 3,074 | 6,921 | OG000 | ClinicalTrials.gov |
| Group 2 | 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. | 630 | 1,932 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants Hospitalised With Severe Exacerbation | ClinicalTrials.gov |
| Description | 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. | ClinicalTrials.gov |
| Time frame | 1 year | ClinicalTrials.gov |
| 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. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness of Triple Therapy in COPD | ClinicalTrials.gov |
| NCT number | NCT03724877 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | Pulmonary Disease, Chronic Obstructive | ClinicalTrials.gov |
| Interventions | Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS), Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA) | ClinicalTrials.gov |
| Lead sponsor | Boehringer Ingelheim | ClinicalTrials.gov |
| Results first posted | 2019-12-03 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03724877?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.