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A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler

Boehringer Ingelheim logo

Boehringer Ingelheim

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Spiolto® Respimat®

Study type

Observational

Funder types

Industry

Identifiers

NCT03663569
1237-0072

Details and patient eligibility

About

Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.

Enrollment

4,819 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent prior to participation
  • Female and male patients ≥40 years of age
  • Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines

Exclusion criteria

  • Patients with contraindications according to Spiolto® Respimat® SmPC
  • Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
  • Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
  • Pregnancy and lactation
  • Current participation in any clinical trial or any other non-interventional study of a drug or device.

Trial design

4,819 participants in 1 patient group

subjects with COPD
Treatment:
Drug: Spiolto® Respimat®

Trial documents
2

Trial contacts and locations

388

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Data sourced from clinicaltrials.gov

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