Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy

Boehringer Ingelheim306 enrolled

Overview

The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.

Purpose:

Study Type

OBSERVATIONAL

Enrollment

306

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spiolto® Respimat®DRUG

observations taken in a period of approximately 6 weeks

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 therapeutic plan recommendation Exclusion criteria: 1. Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (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 Corticosteroids (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

Locations (28)

Outcomes

Primary Outcomes

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

Therapeutic success defined as at least 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 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little" or "no, not limited at all", with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "no, not limited at all"). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.

Time frame: after approximately 6 weeks

Secondary Outcomes

The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2

The 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) and then the median for change from baseline values across all subjects was calculated.

Time frame: Baseline (visit 1) and after approx. week 6 (visit 2)

Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2

The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent

Time frame: Baseline (visit 1) and after approx.week 6 (visit 2)

Patient Overall Satisfaction With Spiolto® Respimat®

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

Data from ClinicalTrials.gov

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