Clinical trial NCT02720757: Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)
Official title: 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: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-03-28
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease (COPD) patients

Brief summary: The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.

A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to 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.


Eligibility criteria: Inclusion criteria:

1. Written informed consent prior to participation
2. Female and male patients = 40 years of age
3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (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 Long-acting beta2 adrenoceptor agonist\\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks.
3. Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-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 Further exclusion criteria apply

Primary outcomes:
measure: Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline
timeFrame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
Secondary outcomes:
measure: Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)
timeFrame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
measure: General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)
timeFrame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
measure: Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
timeFrame: Visit 2 (approx. 6 weeks post baseline)
measure: Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
timeFrame: Visit 2 (approx. 6 weeks post baseline)
measure: Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
timeFrame: Visit 2 (approx. 6 weeks post baseline)
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
city: Multiple Locations
country: Denmark
city: Multiple Locations
country: Luxembourg
city: Multiple Locations
country: Netherlands
city: One Or Multiple Investigational Sites
country: Portugal
city: One Or Multiple Investigational Site
country: Sweden
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Spielmanns M, Tamm M, Schildge S, Valipour A. Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality. J Clin Med Res. 2021 Jul;13(7):392-402. doi: 10.14740/jocmr4542. Epub 2021 Jul 28.