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

Boehringer Ingelheim1,737 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

1,737

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spiolto RespimatDRUG

Tiotropium bromide + Olodaterol

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).

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.

Time frame: after approximately 6 weeks

Secondary Outcomes

Changes in the PF-10 Score From Visit 1 to Visit 2

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).

Time frame: baseline and approx. week 6

General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and 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

Time frame: Baseline (Visit 1) and Week 6 (approx.) (Visit 2)

Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).

At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment.

Time frame: Week 6 (approx.) (Visit 2)

Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).

At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device.

Time frame: Week 6 (approx.) (Visit 2)

Patient Satisfaction With Handling of the Respimat® Inhalation Device at 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

Time frame: Week 6 (approx.) (Visit 2)

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

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes