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Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (both free and fixed combination) for maintenance therapy other than tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) assessed in parallel with the PMS of Tio+Olo FDC Respimat, BI trial number 1237.34

Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (both free and fixed combination) for maintenance therapy other than tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) assessed in parallel with the PMS of Tio+Olo FDC Respimat, BI trial number 1237.34 - Baseline characteristics of patients with COPD (chronic bronchitis, emphysema) who require LABA and LAMA (BI trial number 1237.48)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000023629
Enrollment
500
Registered
2016-08-21
Start date
2016-08-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD(chronic bronchitis, emphysema)

Interventions

None listed

Sponsors

Nippon Boehringer Ingelheim Co.,LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are newly prescribed LABA + LAMA combination (both free and fixed combination) or who are switched to new LABA + LAMA combination from conventional LABA and LAMA combination. Patients with informed consent (excepted in case of opt-out procedure) sequentially to be enrolled by the same physicians in the PMS sites.

Exclusion criteria

Exclusion criteria: Patients who are prescribed Tio+Olo FDC, Patients who have already been registered in this study once (re-entry of patients is not allowed). Patients who are participating in a clinical trial or registry. Patients who have a contraindication to Tio+Olo FDC defined in the package insert for Tio+Olo FDC.

Design outcomes

Primary

MeasureTime frame
Demographics(Sex,date of birth ,height, weight, smoking history, reason of LAMA+LABA administration), COPD status, LAMA + LABA combination administration status, Medical history, Concomitant disease,Previous/concomitant therapies, Concomitant/ past medications, CAT, FVC and FEV1

Countries

Japan

Contacts

Public ContactShuhei Nakamura

Nippon Boehringer Ingelheim Co.,LTD TA Asthma & COPD, Primary Care Medicine, Medicine Division

shuhei.nakamura@boehringer-ingelheim.com03-6417-2471

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026