40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Triple Therapy InitiationPrimary· From index date (cohort entry date) until first occurence of event, up to 42 months.
Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following:
* any LAMA/LABA fixed dose combination + any ICS single formulation
* any LAMA single formulation + any LABA/ICS fixed dose combination
* any LAMA single formulation + any LABA single formulation + any ICS single formulation.
Patients will be censored if they had an occurrence of any of the following: outcome (initiation of
Group
Value
95% CI
Tiotropium/Olodaterol (Spiolto®)
195.0
± 123.2
Tiotropium (Spiriva®)
89.5
± 112.3
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) ExacerbationSecondary· From index date until first occurence of event, up to 42 months.
Time to First Moderate or Severe COPD Exacerbation. Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD.
Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.
Moderate or Severe
Group
Value
95% CI
Tiotropium/Olodaterol (Spiolto®)
116.3
± 108.7
Tiotropium (Spiriva®)
118.8
± 105.9
Moderate Exacerbation
Group
Value
95% CI
Tiotropium/Olodaterol (Spiolto®)
125.6
± 107.4
Tiotropium (Spiriva®)
139.0
± 121.3
Severe Exacerbation
Group
Value
95% CI
Tiotropium/Olodaterol (Spiolto®)
134.0
± 112.5
Tiotropium (Spiriva®)
134.5
± 107.1
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) ExacerbationsSecondary· From index date until first occurence of event, up to 42 months.
Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
Moderate exacerbation is defined as an outpatient visit with a diagnosed code for COPD in any field + a prescription for an oral corticosteroid or an antibiotic for respiratory infections. Severe exacerbations will be defined as a hospitalization with a primary diagnosis for COPD.
Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account
Moderate or Severe Exacerbations
Group
Value
95% CI
Tiotropium/Olodaterol (Spiolto®)
0.08
± 0.33
Tiotropium (Spiriva®)
0.08
± 0.34
Moderate Exacerbations
Group
Value
95% CI
Tiotropium/Olodaterol (Spiolto®)
0.04
± 0.22
Tiotropium (Spiriva®)
0.04
± 0.22
Severe Exacerbations
Group
Value
95% CI
Tiotropium/Olodaterol (Spiolto®)
0.05
± 0.24
Tiotropium (Spiriva®)
0.05
± 0.27
Sponsor's own description
This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 14 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04249310.