ADVAIR DISKUS ADVAIR - GlaxoSmithKline
ADVAIR DISKUS ADVAIR - GlaxoSmithKline
ADVAIR DISKUS ADVAIR - GlaxoSmithKline
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consistent with the recommended use of LABA-containing drugs such as <strong>ADVAIR</strong> ® ,<br />
which should not be introduced as initial therapy in these patients. <strong>ADVAIR</strong> ® should be<br />
used only in patients whose conditions are not adequately controlled using low- to<br />
medium-dose inhaled corticosteroids or the severity of whose disease clearly warrants<br />
the initiation of treatment with two maintenance therapies.<br />
Table 8 below displays the observed likelihood of achieving “Well-Controlled” asthma<br />
and the absolute difference for achieving “Well-Controlled” asthma, when comparing<br />
<strong>ADVAIR</strong> ® with FP alone.<br />
Table 8<br />
Likelihood of achieving “Well-Controlled” asthma in study<br />
SAM40027<br />
Stratum<br />
Likelihood of achieving “Well-Controlled”<br />
asthma (<strong>ADVAIR</strong> ® compared with FP alone)<br />
Absolute difference for achieving “Well-Controlled”<br />
asthma (<strong>ADVAIR</strong> ® compared with FP alone)<br />
Stratum 1 +<br />
Stratum 2<br />
Stratum 3<br />
9% (95%CI: 0%-18%)<br />
31% (95%CI: 19%-44%)<br />
51% (95%CI: 31%-74%)<br />
6% (95%CI: 0%-11%)<br />
16% (95%CI: 10%-22%)<br />
17% (95%CI: 11%-23%)<br />
+ Stratum 1 results did not meet the predetermined 10% difference used to indicate a clinically important difference for<br />
the primary endpoint of achieving “Well-Controlled” asthma<br />
Similar results were observed with “Total Control” of asthma, where more patients<br />
receiving <strong>ADVAIR</strong> ® achieved “Total Control” of asthma versus inhaled FP alone at the<br />
end of Phase I for each individual Stratum + (p
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