Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Striverdi® Respimat®; Drug: Spiriva® Respimat®

Study type: Observational

Funder types: Industry

Identifiers

NCT02173769

1222.56

Details and patient eligibility

About

The decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for COPD patients and affects even the early stages.

Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a marked improvement in physical exercise capacity.

However, there have so far been no data from the daily practice setting about everyday functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2 long-acting bronchodilators.

The objective of this NIS is to measure changes in physical functioning as a surrogate for physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine daily treatment (so-called real life setting).

Enrollment: 1,845 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients >= 40 years
• COPD GOLD 2014 B - D
• Treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat® acc. to the Summary of Product Characteristics (SmPC), no change of routine diagnostics and treatment
• Signed informed consent form before inclusion into the non-interventional study (NIS)

Exclusion criteria

• Patients with contraindications acc. to the Summary of Product Characteristics (SmPC)
• pregnant and breastfeeding women
• patients who are taking part in a different non-interventional study (NIS) or an interventional clinical study at the same time are not to be enrolled

Trial design

1,845 participants in 1 patient group

Adults with COPD

Treatment:

Drug: Spiriva® Respimat®

Drug: Striverdi® Respimat®