OTIVACTO Spain Non Interventional Study

Overview

This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.

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: September 18, 2018

Detailed Description

Purpose:

Study Design:

Arms, Groups and Cohorts

  • Spiolto Respimat
    • QOL measurement of COPD patients taking Spiolto Respimat

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
    • Time Frame: After approximately 6 weeks (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 subdomain 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.

Secondary Measures

  • The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2
    • Time Frame: Baseline (visit 1) and after approx. week 6 (visit 2)
    • The change in Physical functioning questionnaire (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 mean for change from baseline values across all patients was calculated. The PF-10 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.
  • Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2
    • Time Frame: Baseline (visit 1) and after approx.week 6 (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
  • Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2
    • Time Frame: After approx. 6 weeks (visit 2) of treatment initiation
    • A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).
  • Patient Satisfaction With Inhaling From the Respimat® Device
    • Time Frame: After approx. 6 weeks (visit 2) of treatment initiation
    • A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).
  • Patient Satisfaction With Handling of the Respimat® Inhalation Device
    • Time Frame: After approx. 6 weeks (visit 2) of treatment initiation
    • A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

Participating in This Clinical Trial

Inclusion Criteria

1. Written informed consent prior to participation

2. Female and male patients = or > 40 years of age

3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and COPD Global Initiative for Chronic Obstructive Lung Disease (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 Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 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
    • Mireia Canals, +34607550925, Study Chair, mireia.canals@boehringer-ingelheim.com

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