ADVAIR DISKUS ADVAIR - GlaxoSmithKline

FEV 1 and serial FEV 1 results relative to baseline [AUC(bl)] at Treatment Week 1 and
Treatment Week 12, respectively.
Patients’ perceptions of the impact of asthma on their quality of life were assessed with
the Asthma Quality of Life Questionnaire (AQLQ). Patients receiving ADVAIR ®
inhalation aerosol 25/50 mcg had statistically significant (p ≤ 0.006) and clinically
meaningful (≥ 0.5 point difference between groups in mean overall AQLQ score change
from baseline) improvements in overall asthma-related quality of life (mean of 4 AQLQ
domain scores: activity limitation, asthma symptoms, emotional function, and
environmental stimuli) compared with placebo, fluticasone propionate 50 mcg and
salmeterol.
In a one-year study, evaluating the safety of ADVAIR ® inhalation aerosol 25/50 mcg,
25/125 mcg and 25/250 mcg, improvements in FEV 1 (0.17 to 0.35L at 4 weeks) were
seen across all 3-treatment groups and were sustained throughout the 52-week treatment
period. Few patients (3%) were withdrawn due to worsening asthma over 1 year.
The onset of action and progression of improvement in asthma control were evaluated in
3 studies. Following the first dose, the median time to onset of clinically significant
bronchodilation (≥ 15% improvement in FEV 1 ) in most patients was seen within 30 to
60 minutes. Maximum improvement in FEV 1 occurred within 4 hours, and clinically
significant improvement was maintained for 12 hours. Additionally, significant
improvement in morning PEF, asthma symptom scores, and VENTOLIN ® use were
observed within 1 day and in evening PEF within 12 hours after initiating treatment with
the ADVAIR ® inhalation aerosol. Improvement continued over the weeks of therapy in
all 3 studies.
Following the initial dose, predose FEV 1 relative to day 1 baseline improved markedly
over the first week of treatment and continued to improve over the 12 weeks of treatment
in all 3 studies.
Fluticasone Propionate
A 2-year study of patients with asthma receiving CFC-propelled fluticasone propionate
inhalation aerosol (100 and 500 mcg twice daily) demonstrated no statistically significant
changes in bone mineral density at any time point (24, 52, 76, and 104 weeks of double
blind treatment) as assessed by dual-energy x-ray absorptiometry at lumbar region L1 and
L4.
Salmeterol Xinafoate
Salmeterol Multi-center Research Trial (SMART)
The SMART study was a large US post-marketing study that compared the safety of
SEREVENT ® inhalation aerosol (salmeterol 50 mcg twice daily; a component of
ADVAIR ® /ADVAIR ® DISKUS ® ) and placebo, added to the usual asthma therapy for a
28-week treatment period. This study was prematurely terminated after a planned interim
analysis in which a safety issue was identified. This analysis was performed on 26, 355
patients, approximately half of the intended number for enrollment in this trial.
July 29, 2014
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