chronic obstrictive pulnonary disease COPD
Conditions
Interventions
Treatment with Trelegy ELLIPTA or Non-ELLIPTA MITT.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Males and females *40 years of age. * Documented diagnosis of COPD. * COPD Assessment Test (CAT) *10 at screening. * At least one moderate to severe exacerbation in the past 3 years. * Continuous treatment for at least 60 days during the past 16 weeks with inhaled corticosteroid plus long-acting *2-agonist plus long-acting muscarinic antagonist or long-acting *2-agonist plus long-acting muscarinic antagonist or inhaled corticosteroid plus long-acting *2-agonist. In case of dual therapy: A documented indication for triple therapy must be present.
Exclusion criteria
Exclusion criteria: * Woman of childbearing potential. See protocol page 27 for details. * Unstable COPD. See protocol page 27 for details. * Chronic use of oral corticosteroids. See protocol page 27 for details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in COPD Assessment Test (CAT) after 24 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in FEV1 at 24 weeks (subgroup of patients, not in NL). Percentage of participants making at least 1 critical error in inhalation technique (subgroup of patients, not in NL).. | — |
Countries
Netherlands
Outcome results
None listed