OTIVACTO Spain Non Interventional Study

Launched by BOEHRINGER INGELHEIM · Oct 6, 2016

Keywords

ClinConnect Summary

Purpose:

Study Design:

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Written informed consent prior to participation
• • 2. Female and male patients = or \> 40 years of age
• • 3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and 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 Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 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