Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Spiolto® Respimat®

Study type: Observational

Funder types: Industry

Identifiers

NCT03165045

1237-0065

Details and patient eligibility

About

The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.

Full description

The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.

In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.

Enrollment: 1,351 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients can be included if all of the following criteria are met:

• Written informed consent prior to participation
• Female and male patients ≥40 years of age
• Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D)
• Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician.

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

1,351 participants in 1 patient group

patients treated with Spiolto® Respimat®

Description:

Patients with COPD

Treatment:

Drug: Spiolto® Respimat®