MEAN CHANGE FROM BASELINE OVER 12 WEEKS1
STUDY 1: Efficacy and safety in adult patients with mild to moderate asthma over 12 weeks
STUDY 2: Efficacy and safety in pediatric patients with mild asthma over 12 weeks
*Sustained improvement in lung function was demonstrated in two 12-week efficacy and safety asthma clinical studies.
†Average over treatment period: values are adjusted treatment means for the average difference during the treatment period using last observation carried forward (primary endpoint).
‡Comparison of PULMICORT FLEXHALER 180 mcg, 2 inhalations twice daily vs placebo for average over treatment period: P<.001.
‡Comparison of PULMICORT FLEXHALER 90 mcg, 4 inhalations twice daily vs placebo for average over treatment period: P<.001.
STUDY 1: EFFICACY AND SAFETY IN ADULT PATIENTS WITH MILD TO MODERATE ASTHMA OVER 12 WEEKS
NUMBER OF PATIENTS
Week 0: PULMICORT FLEXHALER (n=130), Placebo (n=119). Week 2: PULMICORT FLEXHALER (n=127), Placebo (n=113). Week 4: PULMICORT FLEXHALER (n=115), Placebo (n=86). Week 8: PULMICORT FLEXHALER (n=111), Placebo (n=78). Week 12: PULMICORT FLEXHALER (n=95), Placebo (n=57). Treatment Average: PULMICORT FLEXHALER (n=128), Placebo (n=114).
§Administered as 2 inhalations twice daily.
||Average over treatment period: values are adjusted treatment means for the average difference during the treatment period using last observation carried forward (primary endpoint).
¶Comparison of PULMICORT FLEXHALER 180 mcg, 2 inhalations twice daily vs placebo for average over treatment period: P<.001.
STUDY 2: EFFICACY AND SAFETY IN PEDIATRIC PATIENTS WITH MILD ASTHMA OVER 12 WEEKS
NUMBER OF PATIENTS
Week 0: PULMICORT FLEXHALER (n=93), Placebo (n=104). Week 2: PULMICORT FLEXHALER (n=86), Placebo (n=96). Week 4: PULMICORT FLEXHALER (n=87), Placebo (n=96). Week 8: PULMICORT FLEXHALER (n=81), Placebo (n=91). Week 12: PULMICORT FLEXHALER (n=75), Placebo (n=85). Treatment Average: PULMICORT FLEXHALER (n=90), Placebo (n=101).
§Administered as 4 inhalations twice daily.
||Average over treatment period: values are adjusted treatment means for the average difference during the treatment period using last observation carried forward (primary endpoint).
¶Comparison of PULMICORT FLEXHALER 90 mcg, 4 inhalations twice daily vs placebo for average over treatment period: P<.001.
SIGNIFICANTLY REDUCED ASTHMA SYMPTOM SCORES AND RESCUE MEDICATION USE IN ADULTS1
MEAN CHANGE FROM BASELINE # IN DAYTIME AND NIGHTTIME ASTHMA SYMPTOM SCORES AND DAILY ALBUTEROL USAGE OVER 12 WEEKS2,3
Daytime Symptom Scores2
41% Reduction (n=123)
P<.001**
Nighttime Symptom Scores2
54% Reduction(n=122)
P<.001**
Albuterol Usage3
48% Reduction(n=123)
P<.001**
#Baseline for asthma symptom scores is defined as the mean of the diary values recorded for the 7 days that immediately preceded randomization (values recorded on the day of randomization were excluded). Baseline asthma symptom scores were 1.74 and 0.96 for daytime and nighttime, respectively, for the group receiving PULMICORT FLEXHALER vs 1.75 and 1.00 for the group receiving placebo. Baseline for albuterol usage is defined as the mean of all values obtained during the run-in period. Mean number of albuterol inhalations per day for both groups was 3.39 at baseline.
**P values based on treatment comparison of absolute mean change from baseline for PULMICORT FLEXHALER vs placebo.
Subjects recorded daytime asthma symptom scores in the electronic diary daily, according to the following scale:
Similarly, subjects recorded nighttime asthma symptom scores in the electronic diary, according to the following scale (specific for the period between going to bed in the evening and waking up the next morning):
Study 1: A 12-week efficacy and safety study in adult patients with mild to moderate asthma
A double-blind, multicenter, placebo-controlled, 12-week trial of 621 patients (aged 18 to 80 years) with mild to moderate asthma randomized to PULMICORT FLEXHALER 180 mcg, budesonide via a different dry powder inhaler (DPI) 200 mcg, or placebo, each administered as 1 inhalation once daily, or 2 inhalations twice daily (BID). The study population included patients whose symptoms were previously controlled on inhaled corticosteroids (ICSs). The primary efficacy endpoint was mean change from baseline in FEV1 to the average over the 12-week treatment period.1
Study 2: A 12-week efficacy and safety study in pediatric patients with mild asthma
A double-blind, multicenter, placebo-controlled, 12-week trial enrolled 516 patients (aged 6 to 17 years) with mild asthma randomized to receive PULMICORT FLEXHALER 90 mcg, 2 inhalations once daily or 4 inhalations BID, budesonide via a different DPI 200 mcg, 1 inhalation once daily or 2 inhalations BID, or placebo. The study population included patients previously treated with ICSs for no more than 30 days before the study began (4%) and patients who were naïve to ICSs (96%). The primary efficacy endpoint was mean change from baseline in percent predicted FEV1 to the average over the 12-week treatment period.1
Study 1: A 12-week efficacy and safety study in adult patients with mild to moderate asthma
A double-blind, multicenter, placebo-controlled, 12-week trial of 621 patients (aged 18 to 80 years) with mild to moderate asthma randomized to PULMICORT FLEXHALER 180 mcg, budesonide via a different dry powder inhaler (DPI) 200 mcg, or placebo, each administered as 1 inhalation once daily, or 2 inhalations twice daily (BID). The study population included patients whose symptoms were previously controlled on inhaled corticosteroids (ICSs). The primary efficacy endpoint was mean change from baseline in FEV1 to the average over the 12-week treatment period.1
Study 2: A 12-week efficacy and safety study in pediatric patients with mild asthma
A double-blind, multicenter, placebo-controlled, 12-week trial enrolled 516 patients (aged 6 to 17 years) with mild asthma randomized to receive PULMICORT FLEXHALER 90 mcg, 2 inhalations once daily or 4 inhalations BID, budesonide via a different DPI 200 mcg, 1 inhalation once daily or 2 inhalations BID, or placebo. The study population included patients previously treated with ICSs for no more than 30 days before the study began (4%) and patients who were naïve to ICSs (96%). The primary efficacy endpoint was mean change from baseline in percent predicted FEV1 to the average over the 12-week treatment period.1
Budesonide has an established safety profile for patients 6 years of age and older.
PULMICORT FLEXHALER offers multiple dosing options.
NEXT: BUDESONIDE SAFETY
References:
1. PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2016.
2. Data on File, 2818703, AZPLP.
3. Data on File, 266665, AZPLP.
Reference:
1. PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca; 2010.
Please click here for full Prescribing Information for PULMICORT FLEXHALER.
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