NL-OMON48721
Completed
Phase 4
The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGY ELLIPTA) when Compared with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual Care Setting.(study 206854) - study 206854
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline
- Enrollment
- 700
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\* 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.
Outcomes
Primary Outcomes
Not specified
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Phase 4
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