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Completed

NCT Number: NCT02675517

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent prior to participation
  • Female and male patients = 40 years of age
  • 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

  • Patients with contraindications according to Spiolto® Respimat® SmPC
  • Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
  • 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
  • Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
  • Pregnancy and lactation
  • Patients currently listed for lung transplantation
  • Current participation in any clinical trial or any other non-interventional study of a drug or device

Treatment and study plan

Spiolto Respimat

Drug

Tiotropium bromide + Olodaterol

Primary outcomes

  1. 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 outcomes

  1. 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).

  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

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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