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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Spiriva® Respimat®; 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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2016-03-02
• Results First Submitted QC: 2016-03-02
• Results First Posted: 2016-04-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-06-05

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

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

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