ADVAIR DISKUS ADVAIR - GlaxoSmithKline

“Well-controlled” was defined as two or more of the following 3 criteria:
• Symptom score ∗ of >1 allowed on ≤2 days per week only
• ≤ 2 days and ≤ 4 occasions per week of rescue medication use
• ≥80% predicted morning PEF every day
And all of the following criteria:
• no night-time awakenings,
• no exacerbations # ,
• no side effects enforcing a change in therapy.
“Total Control” was defined as:
• no symptoms, no rescue medication use,
• ≥80% predicted morning PEF every day,
• no night-time awakenings,
• no exacerbations # and
• no side effects enforcing a change in therapy.
Control needed to be sustained, during weeks 5-12, 17-24, or 29-36 in Phase 1, for at
least 6 out of the last 7, or 7 out of the last 8 weeks of treatment to reach the composite
endpoints defined above. Direct measurements of airway inflammation and/or hyperresponsiveness
were not included in these composite endpoints.
Study Results
In each Stratum, more patients receiving ADVAIR ® achieved “Well-Controlled” asthma
versus inhaled FP alone at the end of Phase I (see Table 7, below).
Table 7
Proportion of patients who achieved “Well-Controlled” asthma in
study SAM40027
Primary Endpoint
Associated value and statistical
significance for ADVAIR ® vs. FP
Number of Subjects 2
Proportion of subjects who achieved “Well- Stratum 1: 71% vs. 65% (p=0.039) 1 1083
Controlled” asthma with ADVAIR ®
Stratum 2: 69% vs. 52% (p