N/A
N=1,371,146
Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT04926233 ↗Enrolled (actual)
1,371,146
Serious AEs
—
Results posted
Jul 2021
Primary outcome: Primary: Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US — 65.6; 64.4 Years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tiotropium bromide + Olodaterol (Drug); Sp(t)iolto® Respimat® (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US |
65.6; 64.4 | — |
| PRIMARY Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK |
65.82; 66.17 | — |
| PRIMARY Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis |
1.6; 1.5; 1.9; 1.89; 1.83; 2.31 | — |
| PRIMARY Age of Patients Receiving First Maintenance Treatment - US |
63.0; 62.0; 67.0; 62.0; 62.0; 63.0 | — |
| PRIMARY Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US |
2.0; 2.0; 2.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Characteristics of Patients Receiving First Maintenance Treatment - US |
13803; 2114; 87; 7151; 1632; 486 | — |
| PRIMARY Age of Patients Receiving First Maintenance Treatment - UK |
68.0; 67.0; 67.0; 67.0; 68.0; 70.0 | — |
| PRIMARY Characteristics of Patients Receiving First Maintenance Treatment - UK |
3802; 454; 166; 545; 541; 143 | — |
| PRIMARY Age of Patients Receiving Second Maintenance Treatment - US |
64.0; 63.0; 70.0; 63.0; 63.0; 64.0 | — |
| PRIMARY Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US |
2.0; 2.0; 3.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Characteristics of Patients Receiving Second Maintenance Treatment - US |
3674; 265; 41; 920; 628; 998 | — |
| PRIMARY Age of Patients Receiving Second Maintenance Treatment - UK |
68.0; 68.0; 71.0; 69.0; 68.0; 68.0 | — |
| PRIMARY Characteristics of Patients Receiving Second Maintenance Treatment - UK |
1375; 31; 51; 191; 555; 383 | — |
| SECONDARY Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US |
26242; 3518; 183; 12483; 3818; 676 | — |
| SECONDARY Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK |
5942; 498; 275; 712; 960; 207 | — |
| SECONDARY Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US |
2361; 226; 29; 684; 426; 505 | — |
| SECONDARY Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK |
1351; 34; 63; 172; 590; 299 | — |
| SECONDARY Days Between Index and Initiation of First Maintenance Therapy - US |
158.0; 242.0; 233.0; 165.0; 116.0; 78.0 | — |
| SECONDARY Days Between Index and Initiation of First Maintenance Therapy - UK |
28.5; 708.0; 43.5; 32.0; 19.0; 19.0 | — |
| SECONDARY Days Between First and Second Maintenance Therapy - US |
160.0; 181.5; 176.0; 158.0; 223.0; 143.5 | — |
| SECONDARY Days Between First and Second Maintenance Therapy - UK |
218.0; 239.5; 141.0; 155.5; 284.0; 197.0 | — |
Summary
The primary objectives of the study are to use US and UK data to describe the characteristics of Chronic Obstructive Pulmonary Disease (COPD) patients according to various demographic, lifestyle, clinical, and medication use.
Eligibility Criteria
Inclusion criteria
- parent cohort
-- COPD diagnosis
- child cohort
-- any initiation of first maintenance therapy after July 1, 2015
- grandchild cohort -- any initiation of second maintenance therapy after August 2, 2015
Exclusion criteria
- parent cohort
- age <40 on index date
- any COPD diagnosis in baseline
- any use of long-acting muscarinic antagonists (LAMA), long-acting beta-agonists (LABA), or inhaled corticosteroid (ICS) in baseline
- <365 days of continuous medical and pharmacy coverage
Data sourced from ClinicalTrials.gov (NCT04926233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.