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

Completed
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Adults with COPDSpiriva® Respimat®-
Adults with COPDStriverdi® Respimat®-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Absolute Changes in the PF-10 Score4-6 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 BaselineBaseline

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 Weeks4-6 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 Satisfaction4-6 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 Inhaler4-6 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 Inhaler4-6 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

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Boehringer Ingelheim Investigational Site 1
🇩🇪Aachen, Germany

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