Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Striverdi® Respimat®
- Registration Number
- NCT02173769
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1845
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adults with COPD Spiriva® Respimat® - Adults with COPD Striverdi® Respimat® -
- Primary Outcome Measures
Name Time Method Percentage of Participants With "Therapeutic Success" Baseline and 4-6 weeks 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.
- Secondary Outcome Measures
Name Time Method Absolute Changes in the PF-10 Score 4-6 weeks 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.General Health of the Patient at Baseline 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).General Health of the Patient After 4-6 Weeks 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).Patient Satisfaction: Overall Satisfaction 4-6 weeks 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).Patient Satisfaction: Satisfaction With Inhaler 4-6 weeks 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).Patient Satisfaction: Satisfaction With Handling of Inhaler 4-6 weeks 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).
Trial Locations
- Locations (701)
Boehringer Ingelheim Investigational Site 1
🇩🇪Aachen, Germany
Boehringer Ingelheim Investigational Site 2
🇩🇪Ahaus, Germany
Boehringer Ingelheim Investigational Site 3
🇩🇪Aichtal, Germany
Boehringer Ingelheim Investigational Site 4
🇩🇪Aldenhoven, Germany
Boehringer Ingelheim Investigational Site 5
🇩🇪Alfeld, Germany
Boehringer Ingelheim Investigational Site 6
🇩🇪Altötting, Germany
Boehringer Ingelheim Investigational Site 7
🇩🇪Ansbach, Germany
Boehringer Ingelheim Investigational Site 10
🇩🇪Asbach-Bäumenheim, Germany
Boehringer Ingelheim Investigational Site 8
🇩🇪Asbach-Bäumenheim, Germany
Boehringer Ingelheim Investigational Site 9
🇩🇪Asbach-Bäumenheim, Germany
Scroll for more (691 remaining)Boehringer Ingelheim Investigational Site 1🇩🇪Aachen, Germany