Clinical trial NCT02719639: OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)
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: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 7443
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPDS patients

Brief summary: Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).

Detailed description: Purpose:

Study Design:

Eligibility criteria: Inclusion criteria:

1. Written informed consent prior to participation
2. Female and male patients with more or equal to 40 years of age
3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto Respimat Summary of Product Characteristics (SmPC) and chronic obstructive pulmonary disease (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 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

Primary outcomes:
measure: Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.
timeFrame: Approximately 6 weeks
Secondary outcomes:
measure: Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)
timeFrame: Baseline and week 6
measure: General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).
timeFrame: Baseline and week 6
measure: Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
timeFrame: Approximately 6 weeks
measure: Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
timeFrame: Approximately 6 weeks
measure: Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
timeFrame: Approximately 6 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Austria
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Hungary
city: Multiple Locations
country: Israel
city: Multiple Locations
country: Romania
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Slovakia
city: Multiple Locations
country: Slovenia
city: Multiple Locations
country: Switzerland
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Taube C, Bayer V, Zehendner CM, Valipour A. Assessment of Patient Experiences with Respimat(R) in Everyday Clinical Practice. Pulm Ther. 2020 Dec;6(2):371-380. doi: 10.1007/s41030-020-00127-4. Epub 2020 Aug 28.