ADVAIR DISKUS ADVAIR - GlaxoSmithKline

Clinical Studies in COPD
Clinical study data is provided for a 52-week study.
52-week study
A long term (52 week) clinical study in 1465 COPD patients evaluated the safety and
efficacy of ADVAIR ® DISKUS ® 50/500 (salmeterol xinafoate/fluticasone propionate)
versus placebo and the individual components (salmeterol 50 mcg and fluticasone
500 mcg), all taken twice daily via the DISKUS ® inhalation device. Patients who had an
established clinical history of COPD with a pre-bronchodilator FEV 1 of ≥ 25 to ≤ 70% of
predicted normal, poor reversibility of airflow obstruction (defined as an increase of
< 10% of the predicted normal FEV 1 value following the administration of 400 mcg
salbutamol), and pre-bronchodilator FEV 1 /FVC ratio of ≤ 70% were included in the
study. Patients who had respiratory disorders other than COPD, those requiring long
term oxygen or those who received inhaled or systemic corticosteroids or antibiotic
therapy in the 4 weeks prior to study start were excluded.
The primary measure of efficacy was pre-bronchodilator FEV 1 .
Pre-bronchodilator FEV 1 in the ADVAIR ® DISKUS ® 50/500 group was 133mL higher
than the placebo group (p < 0.001), 73mL higher than the salmeterol 50 mcg group
(p < 0.001) and 95 mL higher than the fluticasone 500 mcg group (p < 0.001) throughout
the treatment period.
Disease-specific quality of life was assessed with the St. George's Respiratory
Questionnaire (SGRQ). With ADVAIR ® DISKUS ® 50/500, the raw mean changes in
Total Score ranged from -2.4 at Week 2 to -4.5 at Week 52. A clinically meaningful
change of > 4.0 was achieved as early as 8 weeks with ADVAIR ® DISKUS ® 50/500 but
not with placebo, salmeterol 50 mcg or fluticasone 500 mcg.
The overall incidence of adverse events and COPD-related adverse events was similar
across the four groups during the treatment period. Most commonly reported drugrelated
adverse event was candidiasis of the mouth and throat (ADVAIR ® DISKUS ®
50/500 mcg, 6%; fluticasone 500 mcg, 6%; salmeterol 50 mcg, 1%; placebo, 1%). Lower
respiratory tract infections and pneumonia occurred in 7% of patients in the placebo and
salmeterol groups compared to 12% and 14% in the fluticasone propionate 500 mcg and
ADVAIR ® DISKUS ® 50/500 mcg groups respectively.
No clinically significant effects were observed following any treatment on ECG findings,
vital signs or bruise count.
Bone density and fracture rates were not assessed in this study.
July 29, 2014
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