AstraZeneca

PULMICORT RESPULES significantly reduces rescue
ß2-agonist use 1,2

Studies show that PULMICORT RESPULES significantly reduced the number of days rescue ß2-agonists were required and significantly improved daytime and nighttime symptoms, and improved lung function.1,2

SIGNIFICANTLY REDUCED RELIANCE ON SHORT-ACTING

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PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.

PULMICORT RESPULES is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.

Note: The baseline values for the mean number of days breakthrough medication was used by patients taking placebo or PULMICORT RESPULES, 0.25 mg or 0.5 mg twice daily, were 11.8, 11.6, and 12.0, respectively.

Among ICS‡-dependent children 4 to 8 years of age with persistent asthma, Shapiro and colleagues documented that PULMICORT RESPULES administered twice daily significantly reduced the number of days breakthrough medication was required compared to placebo1

Study Design

  • Multicenter, double-blind, placebo-controlled, parallel-group study to determine efficacy and safety of twice-daily doses of PULMICORT RESPULES
  • 178 pediatric patients (4 to 8 years of age) dependent on inhaled steroids randomized to receive 0.25 mg, 0.5 mg, 1 mg, or placebo for 12 weeks
  • Measurements were recorded at 2, 4, 8, and 12 weeks during the 12-week study period
  • Over the 12-week period, rescue ß2-agonist use was reduced by a mean of 3.1, 5.6, and 6.7 days in the placebo, 0.25-mg, and 0.50-mg groups respectively

Footnotes

‡ ICS—Inhaled corticosteroids
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Indication and Important Safety Information

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children ages 12 months to 8 years.

PULMICORT RESPULES is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.

Common adverse events reported in clinical trials, regardless of relationship to treatment, included respiratory infection, rhinitis, coughing, otitis media, viral infection, gastroenteritis, ear infection, oral thrush/candidiasis, and epistaxis.

Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.

PULMICORT RESPULES, like other inhaled corticosteroids, may impact the hypothalamic-pituitary-adrenal axis, especially in susceptible individuals, in young children, and in patients given high doses for prolonged periods.

Particular care is needed for patients who are transferred from systemically active corticosteroids to less systemically available corticosteroids, because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids (see WARNINGS in full Prescribing Information).

Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles.

[Please see accompanying full Prescribing Information.]

References

  1. Shapiro G, Mendelson L, Kraemer MJ, et al. Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid-dependent, persistent asthma. J Allergy Clin Immunol. 1998:102:789-796.
  2. Data on file, DA-RES-09.