Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD, Chronic Bronchitis, Emphysema
Brief summary
This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.
Detailed description
Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD.
Exclusion criteria
* Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD. * Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in morning PEF | — |
| Changes in pre-dose FVC, V50, V25 | — |
| Use of rescue medication | — |
| Changes in symptom scores | — |
Countries
Japan
Outcome results
None listed