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

Study Overview
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Brief Summary
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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).

Official Title
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AKTIV: Changes in Physical Functioning in Patients With COPD During Therapy With a Combination of Spiriva® Respimat® + Striverdi® Respimat® or Spiriva® 18 Mikrogramm + Striverdi® Respimat®

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Spiriva® Respimat®
* Drug: Striverdi® Respimat®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with COPD<br> | Drug: Spiriva® Respimat®<br>* Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®<br>Drug: Striverdi® Respimat®<br>* Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Therapeutic Success | Percentage of participants with therapeutic success defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. | Baseline and 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Changes in the PF-10 Score | Absolute changes in the PF-10 score. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. | 4-6 weeks | 
| General Health of the Patient at Baseline | General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent). | Baseline | 
| General Health of the Patient After 4-6 Weeks | General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent). | 4-6 weeks | 
| Patient Satisfaction: Overall Satisfaction | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). | 4-6 weeks | 
| Patient Satisfaction: Satisfaction With Inhaler | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). | 4-6 weeks | 
| Patient Satisfaction: Satisfaction With Handling of Inhaler | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). | 4-6 weeks |