ADVAIR DISKUS ADVAIR - GlaxoSmithKline

In a randomized, double-blind, active-controlled trial involving 267 patients aged
12 years and over, who were uncontrolled on short-acting beta 2 -agonist therapy,
treatment with 50/100 mcg salmeterol xinafoate/fluticasone propionate DISKUS ®
demonstrated superior efficacy and comparable safety compared with salmeterol
(50 mcg) or fluticasone propionate (100 mcg) alone. ADVAIR ® DISKUS ® 50/100 mcg
was proven to be significantly more efficacious than salmeterol alone for the mean
change from baseline in morning pre-dose FEV 1 at endpoint (p = 0.036). In addition,
ADVAIR ® DISKUS ® achieved significantly better results than fluticasone propionate
alone for area under the serial FEV 1 curve at treatment week 12 relative to baseline
(p = 0.021). Lung function parameters, asthma symptoms, and VENTOLIN ® use all
showed statistically significant and clinically relevant improvements with the
combination product compared with its individual components.
Two, randomized, double-dummy, parallel-group, 12-week comparative trials of
ADVAIR ® DISKUS ® 50/100 mcg versus oral montelukast 10 mg once-daily were
conducted. 855 patients 15 years and older with persistent asthma inadequately
controlled with scheduled or as needed short-acting beta 2 -agonists alone were enrolled.
In both trials, ADVAIR ® DISKUS ® was significantly more efficacious (p < 0.001,
morning pre-dose FEV 1 ) and has a similar tolerability and adverse event profile
compared to the once-daily montelukast.
Use in children
The efficacy of ADVAIR ® DISKUS ® 50/100 mcg was compared to concurrent therapy
with salmeterol xinafoate and fluticasone propionate administered via separate inhalers in
children 4-11 years old. The adjusted mean change in morning PEFR from baseline for
Weeks 1-12 were 33L/min for the combination product and 28L/min for concurrent
therapy. Patients responded similarly in both treatment groups with marked reduction of
asthma symptoms and VENTOLIN ® use during the study.
ADVAIR ® Inhalation Aerosol
Use in adolescents and adults
In clinical trials comparing ADVAIR ® inhalation aerosol with individual components,
improvements in most efficacy endpoints were greater with ADVAIR ® inhalation aerosol
than with the use of either fluticasone propionate or salmeterol alone. In addition,
clinical trials showed comparable results between ADVAIR ® inhalation aerosol and
ADVAIR ® DISKUS ® .
When compared to salmeterol alone, ADVAIR ® inhalation aerosol was significantly
more efficacious in terms of asthma stability (probability of remaining in the study and
change from baseline at endpoint in morning predose FEV 1 ). ADVAIR ® inhalation
aerosol was comparable or superior to salmeterol in area under the 12-hour serial FEV 1
curve relative to baseline [AUC(bl)] at Treatment Week 1 and Treatment Week 12,
respectively.
When compared to fluticasone propionate alone, patients receiving ADVAIR ® inhalation
aerosol had significantly greater increases from baseline at endpoint in morning predose
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