Overview

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

Status:
Terminated

Trial end date:
2017-12-14

Target enrollment:
0

Participant gender:
All

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.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Boehringer Ingelheim

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