Status:
COMPLETED
Greek NIS Spiolto ELLACTO
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
Open-label observational study: including COPD patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations
Eligibility Criteria
Inclusion
- Therapeutic indication before entering the enrollment face is patients diagnosed with COPD requiring a combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and guidelines, COPD GOLD 2017 groups B to D
- Female and male patients ≥40 years of age
- Treatment with Spiolto ® Respimat® acc. to SmPC and at the discretion of the physician
- Written informed consent prior to participation
Exclusion
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 weeks or patients already on a combination of LAMA and LABA therapy; either as a fixed combination product or as separate components Note: Patients previously treated with LABA or LAMA (with or without ICS) are eligible to be included in the study
- 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
- Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
- Pregnancy and lactation
- Patients currently listed for lung transplantation
- Current participation in any clinical trial or any other non-interventional study of a drug or device
Key Trial Info
Start Date :
March 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 3 2019
Estimated Enrollment :
1360 Patients enrolled
Trial Details
Trial ID
NCT03419962
Start Date
March 19 2018
End Date
April 3 2019
Last Update
April 27 2020
Active Locations (15)
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1
Metropolitan
Aegina, Greece, 18547
2
Metroplitan
Athens, Greece, 18547
3
Metropolitan
Athens, Greece, 18547
4
Metropolitan
Chania, Greece, 18547