DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02552160

D6570R00001

Details and patient eligibility

About

Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.

Full description

Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.

Enrollment: 3,732 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female/male of at least 40 years of age
• Patient diagnosed with COPD
• Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).
• Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).
• Signed declaration of consent

Exclusion criteria

• The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.
• Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.
• Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.
• Patient is participating in a clinical trial.

Trial design

3,732 participants in 3 patient groups

Patients on Duaklir® Genuair®

Description:

Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)

Patients on Ultibro® Breezhaler®

Description:

Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)

Patients on Anoro®

Description:

Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)