At a glance
ClinicalIndex Comparison RecordN/ACompleted· 7,443 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
An observational study for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 7,443 participants across 9 sites in 9 countries.
Detailed 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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustria, Czechia, Hungary, Israel, Romania, Russia, Slovakia, Slovenia, Switzerland
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionMay 2017
TodayJul 2026
First PostedMar 25, 2016
Enrollment StartApr 1, 2016
Primary CompletionMay 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.3 years ago