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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 10, 2017

Interventions

  • Drug: Spiolto Respimat
    • Tiotropium bromide + Olodaterol

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).
    • Time Frame: 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 Measures

  • Changes in the PF-10 Score From Visit 1 to Visit 2
    • Time Frame: 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.
    • Time Frame: 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 Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).
    • Time Frame: Week 6 (approx.) (Visit 2)
    • At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment.
  • Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).
    • Time Frame: Week 6 (approx.) (Visit 2)
    • At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device.
  • Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

1. Written informed consent prior to participation

2. Female and male patients = 40 years of age

3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation

Exclusion Criteria

1. Patients with contraindications according to Spiolto® Respimat® SmPC

2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months

3. Patients continuing LABA- Inhalative Corticosteroides (iCS)treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists

4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks

5. Pregnancy and lactation

6. Patients currently listed for lung transplantation

7. Current participation in any clinical trial or any other non-interventional study of a drug or device

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

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