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)
- Conditions
- chronic obstrictive pulnonary diseaseCOPD10006436
- Registration Number
- NL-OMON48721
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 700
* 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.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in COPD Assessment Test (CAT) after 24 weeks of treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change from baseline in FEV1 at 24 weeks (subgroup of patients, not in NL).<br /><br>Percentage of participants making at least 1 critical error in inhalation<br /><br>technique (subgroup of patients, not in NL)..</p><br>