Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Spiolto Respimat

• Registration Number: NCT02675517
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Study First Submitted: 2016-01-29
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Primary Completion: 2017-03-10
• Study Completion: 2017-04-11
• Status Verified: 2018-03
• Results First Submitted: 2018-03-12
• Results First Submitted QC: 2018-03-12
• Last Update Submitted: 2018-03-12
• Results First Posted: 2018-10-15
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1737

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spiolto Respimat	Spiolto Respimat	COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD)guidelines

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).	after approximately 6 weeks	Therapeutic success defined as a minimum 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).	Week 6 (approx.) (Visit 2)	At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device.
Changes in the PF-10 Score From Visit 1 to Visit 2	baseline and approx. week 6	Change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2).
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.	Baseline (Visit 1) and Week 6 (approx.) (Visit 2)	Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).	Week 6 (approx.) (Visit 2)	At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).	Week 6 (approx.) (Visit 2)	At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment.