PULMICORT FLEXHALER [package insert], 2010. AstraZeneca LP, Wilmington, DE.
Data on File, 266665, AZPLP.
US Food and Drug Administration. CFR-Code of Federal Regulations Title 21. http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=201.57. Accessed November 27, 2012.
Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000;343(15):1054-1063.
Data on File, 268208, AZPLP.
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.
Labiris NR, Dolovich MB. Pulmonary drug delivery, Part II: the role of inhalant delivery devices and drug formulations in therapeutic effectiveness of aerosolized medications. Br J Clin Pharmacol. 2003;56(6):600-612.

PULMICORT FLEXHALER provided significant and sustained improvement in lung function1

Efficacy in adult patients
Efficacy in pediatric patients

In adults with mild to moderate asthma

PULMICORT FLEXHALER provided significant and sustained improvement in lung function1

Mean change from baseline in FEV1 (L)1 chart

1

Study 1: A 12-week efficacy and safety study in adults with mild to moderate asthma.

Improvement in mean change from baseline in FEV1, the primary efficacy end point in this study, was statistically significant vs placebo over 12 weeks (P<.001)1
PULMICORT FLEXHALER significantly improved secondary end points of morning and evening peak expiratory flow (PEF), daytime and nighttime asthma symptom severity, and rescue medication use vs placebo1,2

PULMICORT FLEXHALER significantly reduced rescue medication use1,2

Reduction in albuterol use over 12 weeks chart

1

Study 1: A 12-week efficacy and safety study in adults with mild to moderate asthma.

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View footnotes and study design

View footnotes and study design

Footnotes

aAverage over treatment period: values are adjusted treatment means for the average difference during the treatment period using last observation carried forward (primary end point).

bComparison of PULMICORT FLEXHALER 180 mcg, 2 inhalations twice daily vs placebo for average over treatment period: P<.001.

Study design

Study 1: A 12-week efficacy and safety study in adults with mild to moderate asthma: A multicenter, placebo-controlled, 12-week trial of 621 adults aged 18 to 80 years with mild to moderate asthma (mean baseline percent predicted forced expiratory volume in 1 second [FEV1], 64.3%) randomized to receive PULMICORT FLEXHALER 180 mcg, a different budesonide dry-powder inhaler 200 mcg, or placebo, administered as 1 inhalation once daily or 2 inhalations twice daily. Patients’ symptoms were previously controlled on inhaled corticosteroids (ICSs). Mean number of albuterol inhalations per day for the group receiving PULMICORT FLEXHALER was 3.39 at baseline.1,2

References:

  1. PULMICORT FLEXHALER [package insert], 2010. AstraZeneca LP, Wilmington, DE.
  2. Data on File, 266665, AZPLP.

 (or click anywhere on screen)

In pediatric patients with mild asthma

PULMICORT FLEXHALER provided significant and sustained improvement in lung function1

Mean change from baseline in percent predicted FEV1 chart

1

Study 2: A 12-week efficacy and safety study in pediatric patients with mild asthma.

View footnotes and study design

View footnotes and study design

Footnotes

aAverage over treatment period: values are adjusted treatment means for the average difference during the treatment period using last observation carried forward (primary end point).

bComparison of PULMICORT FLEXHALER 90 mcg, 4 inhalations twice daily vs placebo for average over treatment period: P<.001.

Study design

Study 2: A 12-week efficacy and safety study in pediatric patients with mild asthma: A multicenter, placebo-controlled, 12-week trial enrolled 516 patients aged 6 to 17 years with mild asthma (mean baseline percent predicted forced expiratory volume in 1 second [FEV1], 84.9%) randomized to receive PULMICORT FLEXHALER 90 mcg, 2 inhalations once daily or 4 inhalations twice daily, a different budesonide dry-powder inhaler 200 mcg, 1 inhalation once daily or 2 inhalations twice daily, or placebo. The study population included patients previously treated with inhaled corticosteroids (ICSs) for no more than 30 days before the study began (4%) and patients who were naïve to ICSs (96%).1

References:

  1. PULMICORT FLEXHALER [package insert], 2010. AstraZeneca LP, Wilmington, DE.

 (or click anywhere on screen)

1

Improvement in mean change from baseline in percent predicted FEV1, the primary efficacy end point in this study, was statistically significant vs placebo over 12 weeks (P<.001)1
PULMICORT FLEXHALER significantly improved secondary end points of morning and evening peak expiratory flow (PEF) vs placebo1
PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm

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940006-3014809 Last Updated 8/14

IMPORTANT SAFETY INFORMATION ABOUT PULMICORT FLEXHALER

  • 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.PDF

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.