print_label | resize_label

PULMICORT FLEXHALER Efficacy

Significant and sustained* effect on lung function for adult and pediatric patients1

 

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.

  • Statistically significant improvement vs placebo in secondary endpoints of morning and evening peak expiratory flow, daytime and nighttime asthma symptom scores, and daily rescue medication use in adult patients (P<.001)1
  • PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older
  • PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for relief of acute bronchospasm
  • Adverse reactions that occurred at a rate of ≥1% are: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, and oral candidiasis
  • Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown
  • Statistically significant improvement vs placebo in secondary endpoints of morning and evening peak expiratory flow in pediatric patients (P<.001)1
  • PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older
  • PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for relief of acute bronchospasm
  • Adverse reactions that occurred at a rate of ≥1% are: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, and oral candidiasis
  • Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown

STUDY 1: EFFICACY AND SAFETY IN ADULT PATIENTS WITH MILD TO MODERATE ASTHMA OVER 12 WEEKS

Improvement in FEV1 (L)1 (12-week study)

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.

VIEW STUDY DESIGN

STUDY 2: EFFICACY AND SAFETY IN PEDIATRIC PATIENTS WITH MILD ASTHMA OVER 12 WEEKS

Improvement in FEV1 (L)1 (12-week study)

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.

VIEW STUDY DESIGN

 

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.

  • Statistically significant improvement vs placebo in mean change from baseline in FEV1 over 12 weeks, the primary efficacy endpoint in this study (P<.001)1
  • Statistically significant improvement vs placebo in secondary endpoints of morning and evening peak expiratory flow, daytime and nighttime asthma symptom scores, and daily rescue medication use (P<.001)1
 

SYMPTOM SCORING

Subjects recorded daytime asthma symptom scores in the electronic diary daily, according to the following scale:

  • 0 = None. No symptoms of asthma present.
  • 1  = Mild. Asthma symptoms noticeable but not bad enough to cause trouble with activities; no rescue medication required.
  • 2 = Moderate. Asthma symptoms noticed often and caused some interference with daily routines and activities; required the use of rescue medication.
  • 3 = Severe. Asthma symptoms continuous or present most of the day and severely restricted daily routine and activities.

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):

  • 0 = None. No symptoms of asthma present.
  • 1  = Mild. Awoke once because of asthma or cough, or both, but did not use rescue medication.
  • 2 = Moderate. Awoke at least once because of asthma or cough, or both, and used rescue medication.
  • 3 = Severe. Awake most of the night because of asthma or cough, or both.
 

PLACEBO COMPARISON

  • Mean change in asthma symptom scores and rescue medication use over 12 weeks for placebo (%):
  • Daytime Asthma Symptom Score: -22% (n=110)
  • Nighttime Asthma Symptom Score: -24% (n=112)
  • Rescue Medication Use: -8% (n=112)

STUDY DESIGNS

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 DESIGNS

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

NEXT: BUDESONIDE SAFETY

References:

1.  PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca; 2010.

2. Data on File, 2818703, AZPLP.

3. Data on File, 266665, AZPLP.

Reference:

1.  PULMICORT FLEXHALER Prescribing Information. Wilmington, DE: AstraZeneca; 2010.

IMPORTANT SAFETY INFORMATION AND INDICATION

  • PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.
  • Particular care is needed for patients who are transferred from systemically active corticosteroids to PULMICORT FLEXHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
  • Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses.
  • Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.
  • Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids.
  • Hypersensitivity reactions, including anaphylaxis, have been reported with budesonide.
  • PULMICORT FLEXHALER contains small amounts of lactose, which contains trace levels of milk proteins. In patients who have severe milk protein allergy (not those who are lactose intolerant) cough, wheezing, or bronchospasm may occur.
  • Adverse reactions that occurred at a rate of ≥ 1% are: nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, nausea, viral gastroenteritis, otitis media, and oral candidiasis.

INDICATION

  • PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age or older.

Please click here for full Prescribing Information for PULMICORT FLEXHALER.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.