Proven asthma control* across multiple measures
in adults and children1,2
- Efficacy results in children were similar to those observed in adults1
- Within 24 hours of taking budesonide, improvement in asthma control was observed, although maximum benefit may not be achieved for 1 to 2 weeks, or longer1
View footnotes and study design
Footnote
*Asthma control was measured by lung function improvements in both adult and pediatric patients in clinical trials for PULMICORT FLEXHALER. The primary endpoint in the adult pivotal trial was mean change from baseline in forced expiratory volume in 1 second (FEV1). In the pediatric pivotal trial, the primary endpoint was change in % predicted FEV1. Additional measures of control (secondary efficacy endpoints) included morning and evening peak expiratory flow (PEF) (in both adults and children) and daytime and nighttime asthma symptom severity and rescue medication use (in adults).
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 with mild to moderate asthma (mean baseline percent predicted FEV1, 64.3%) randomized to receive PULMICORT FLEXHALER 180 mcg, the previous budesonide formulation 200 mcg, or placebo, administered as 1 inhalation once daily or 2 inhalations twice daily. Patients’ symptoms were previously controlled on ICSs. Mean number of albuterol inhalations per day for the group receiving PULMICORT FLEXHALER was 3.39 at baseline.1,2
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 FEV1, 84.9%) randomized to receive PULMICORT FLEXHALER 90 mcg, 4 inhalations twice daily, the previous budesonide formulation 200 mcg, 2 inhalations twice daily, or placebo. The study population included patients previously treated with inhaled corticosteroids for no more than 30 days before the study began (4%) and patients who were naive to ICSs (96%).1
(or click anywhere on screen)
- Improvement in the primary efficacy endpoints of mean change from baseline in FEV1 (adult study) and mean change from baseline in percent predicted FEV1 (pediatric study) was statistically significant vs placebo over 12 weeks in both studies (P<.001)1
- In adult patients, PULMICORT FLEXHALER significantly improved secondary endpoints of morning and evening PEF, daytime and nighttime asthma symptom severity, and rescue medication use vs placebo1,2
- In pediatric patients, PULMICORT FLEXHALER significantly improved secondary endpoints of morning and evening PEF vs placebo1
- PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm
In adults with mild to moderate asthma
PULMICORT FLEXHALER significantly reduced rescue medication use over 12 weeks vs placebo2
Reduction in albuterol use over 12 weeks2
Study 1: A 12-week efficacy and safety study in adults with mild to moderate asthma.
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 endpoint).
bComparison of PULMICORT FLEXHALER 180 mcg, 2 inhalations twice daily vs placebo for average over treatment period: P<0.001.
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 with mild to moderate asthma (mean baseline percent predicted FEV1, 64.3%) randomized to receive PULMICORT FLEXHALER 180 mcg, the previous budesonide formulation 200 mcg, or placebo, administered as 1 inhalation once daily or 2 inhalations twice daily. Patients’ symptoms were previously controlled on ICSs. Mean number of albuterol inhalations per day for the group receiving PULMICORT FLEXHALER was 3.39 at baseline.1,2
(or click anywhere on screen)
PULMICORT FLEXHALER significantly improved lung function (FEV1) over 12 weeks vs placebo1
Mean change from baseline in FEV1(L)1
Study 1: A 12-week efficacy and safety study in adults with mild to moderate asthma.
View footnotes and study designView 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 endpoint).
bComparison of PULMICORT FLEXHALER 180 mcg, 2 inhalations twice daily vs placebo for average over treatment period: P<0.001.
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 with mild to moderate asthma (mean baseline percent predicted FEV1, 64.3%) randomized to receive PULMICORT FLEXHALER 180 mcg, the previous budesonide formulation 200 mcg, or placebo, administered as 1 inhalation once daily or 2 inhalations twice daily. Patients’ symptoms were previously controlled on ICSs. Mean number of albuterol inhalations per day for the group receiving PULMICORT FLEXHALER was 3.39 at baseline.1,2
(or click anywhere on screen)
- Improvement in mean change from baseline in FEV1, the primary efficacy endpoint in this study, was statistically significant vs placebo over 12 weeks (P<.001)1
- PULMICORT FLEXHALER significantly improved secondary endpoints of morning and evening PEF and daytime and nighttime asthma symptom severity vs placebo1
- PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm
In pediatric patients with mild asthma
PULMICORT FLEXHALER significantly improved lung function (percent predicted FEV1) over 12 weeks vs placebo1
Mean change from baseline in percent predicted FEV11
Study 2: A 12-week efficacy and safety study in pediatric patients with mild asthma.
View footnotes and study designView 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 endpoint).
bComparison of PULMICORT FLEXHALER 90 mcg, 4 inhalations twice daily vs placebo for average over treatment period: P<0.001.
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 FEV1, 84.9%) randomized to receive PULMICORT FLEXHALER 90 mcg, 4 inhalations twice daily, the previous budesonide formulation 200 mcg, 2 inhalations twice daily, or placebo. The study population included patients previously treated with inhaled corticosteroids for no more than 30 days before the study began (4%) and patients who were naive to ICSs (96%).1
(or click anywhere on screen)
- Improvement in mean change from baseline in FEV1, the primary efficacy endpoint in this study, was statistically significant vs placebo over 12 weeks (P<.001)1
- PULMICORT FLEXHALER significantly improved secondary endpoints of morning and evening PEF vs placebo1
- PULMICORT FLEXHALER is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm
IMPORTANT INFORMATION ABOUT PULMICORT FLEXHALER
Important Safety Information
- 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
- Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles
- 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.
PULMICORT FLEXHALER is a registered trademark of the AstraZeneca group of companies.
This product information is intended for US health care professionals only.
©2011 AstraZeneca. All rights reserved. 1093306 1/12
