Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)
Phase 4
Completed
- Conditions
- COPDchronic obstructive pulmonary disease1000595910038716
- Registration Number
- NL-OMON44651
- Lead Sponsor
- GlaxoSmithKline BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
* COPD patients *40 years of age (see protocol page 16 for details).
* (Ex) smokers, at least 10 pack years.
* Pre and post salbutamol FEV1/FVC ratio <70%.
* Post salbutamol FEV1 *50% and *70% of predicted.
* At least one native hip..
* Safe contraception for women of childbearing potential.
Exclusion Criteria
* Pregnancy, lactation.
* Bronchial asthma.
* Poorly controlled COPD (see protocol page 17 for details).
* Bone disorders (see protocol page 17 for details).
* Immobility.
* Low vitamin D (see protocol page 18 for details)
* Use of prohibited medication (see protocol page 19 for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Bone mineral density hip.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Bone mineral density lumbar spine. Adverse events.</p><br>