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No Significant Growth Velocity Changes in Two Trials Evaluating the Potential Effects of Flunisolide HFA (AerospanTM) on Growth in Pediatric Patients with Mild-to-Moderate Asthma
Monday, March 7, 2016
South Exhibit Hall H (Convention Center)
George W. Bensch, MD FAAAAI, David P. Skoner, MD
Rationale:

Two 1-year clinical trials were performed with flunisolide HFA, a small-particle inhaled corticosteroid with a built-in spacer, approved for the treatment of asthma in patients 6 years and older.  Post-hoc analyses evaluated height changes and growth velocity changes from baseline after 52 weeks of treatment with flunisolide HFA 160 mcg BID (max approved dose in children 6 to 11).

Methods:

The first study was a double-blind, randomized 1-year safety study of flunisolide HFA and placebo in children 4 to 9 with mild-to-moderate asthma (n=218).  The second study was an open-label, randomized, 1-year safety study of flunisolide HFA, inhaled beclomethasone (BDP) CFC, and inhaled cromolyn (negative control) in children 4 to 11 with mild-to-moderate asthma (n=206).  Each study was analyzed similarly for growth velocity (via stadiometry assessments) over 1 year.

Results:

In the double-blind study, mean growth velocity was 6.01 cm/yr for flunisolide HFA versus 6.19 cm/yr for placebo, a non-significant difference (p=0.425).  Distribution in height changes and growth velocity changes were similar between flunisolide HFA and placebo. In the open-label study, mean growth velocity was 6.2 cm/yr for the flunisolide HFA group versus 5.3 cm/yr for the BDP group (p=0.008) and 6.9 cm/yr for the cromolyn group (p=0.254).  Distribution of height changes and growth velocity changes was similar between flunisolide HFA and cromolyn.

Conclusions:

Two 1-year trials demonstrated that flunisolide HFA did not result in significant growth suppression in pre-pubescent pediatric asthma patients 4 to 11 years of age when compared to placebo or negative control.