Greek NIS Spiolto ELLACTO

Boehringer Ingelheim

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: MaxSpiolto® Respimat® 160 Characters...

Study type

Observational

Funder types

Industry

Identifiers

NCT03419962

1237-0073

Details and patient eligibility

About

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

Enrollment

1,360 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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