Adverse reactions occurring at an incidence of ≥1% and more common than placebo in the PULMICORT FLEXHALER group (pooled data from two 12-week, double-blind, placebo-controlled clinical trials in asthma patients ≥6 years of age)*1
*In non-placebo-controlled, long-term studies in children (at doses up to 360 mcg daily) and adolescent and adult subjects (at doses up to 720 mcg daily) treated for up to 1 year with PULMICORT FLEXHALER, a similar pattern and incidence of adverse reactions were revealed.
HPA*-axis function in adult and pediatric patients taking budesonide over 52 weeks2,3
A 52-week efficacy and safety study in adult and pediatric patients with mild to severe asthma
A 52-week, multicenter, open-label extension trial of 1133 patients (aged 6 to 70 years) with mild to severe asthma who received budesonide via a different DPI (dose range: 200 mcg/day to 1600 mcg/day). Patients included adults (n=249) who did not receive corticosteroids, adults (n=384) and children (n=356) previously maintained on ICSs, and adults (n=144) previously maintained on oral corticosteroids.The primary efficacy endpoint was mean change from baseline in percent predicted FEV1.2
Growth in patients taking budesonide and placebo over 4 years1,2
*Administered twice daily
Children treated with inhaled budesonide had a 1.1-cm reduction in growth compared with those receiving placebo.1,2
The difference between these treatment groups did not increase further.1,2
Similar growth velocities between the 2 treatment groups.1,2
Childhood Asthma Management Program (CAMP) study in pediatric patients with mild to moderate asthma
A double-blind, multicenter trial of 1041 patients (aged 5 to 12 years) with mild to moderate asthma randomized to receive budesonide via a different DPI 200 mcg BID (n=311), a mast-cell stabilizer (n=312), or placebo (n=418) over a 4- to 6-year period. The primary efficacy endpoint of mean change in percent predicted FEV1 after administration of a bronchodilator was not met. Physical growth was a secondary endpoint.2 Note: Recommended starting dosage of PULMICORT FLEXHALER for pediatric patients aged 6 to 17 years is 180 mcg, BID.1
Reference:
1. PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2016.
References:
1. PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca; 2010.
2. Tinkelman DG, Bronsky EA, Gross G, Schoenwetter WF, Spector SL. Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma. J Asthma. 2003;40(3):225-236.
3. Data on File, 268208, AZPLP.
Reference:
1. PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2016.
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