NCT02720757

Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Spiolto Respimat	Tiotropium bromide + Olodaterol

Timeline

• Start date: 2016-08-26
• Primary completion: 2017-12-14
• Completion: 2017-12-14
• First posted: 2016-03-28
• Last updated: 2019-04-16
• Results posted: 2019-04-16

Locations

6 sites across 6 countries: Belgium, Denmark, Luxembourg, Netherlands, Portugal, Sweden