AstraZeneca

PULMICORT RESPULES improves lung function*1

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PULMICORT RESPULES improved peak expiratory flow (PEF)

Note: Improvements in lung function were based on evaluations of patients capable of performing lung function testing.

In a placebo-controlled study of 469 children 12 months to 8 years of age, Baker and colleagues noted that patients treated with PULMICORT RESPULES 0.25 mg or 0.5 mg twice daily or 1 mg once daily had significantly improved morning peak expiratory flow compared to placebo.1

In addition, PULMICORT RESPULES resulted in significantly reduced reliance on short-acting ß2-agonists.1

Study Design

  • Multicenter, double-blind, placebo-controlled, parallel-group study to determine efficacy and safety of once- and twice-daily doses of PULMICORT RESPULES
  • 469 pediatric patients (12 months to 8 years of age) randomized to receive 0.25 mg or 1 mg once daily, or 0.25 mg or 0.5 mg twice daily, or placebo

The use of ICS controller therapy in patients with persistent asthma significantly reduced exacerbations compared to non-ICS controller therapy.

Footnote

‡ Based on ANOVA performed on log-transformed exacerbation rates.
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Learn about the demonstrated safety of PULMICORT RESPULES

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. Baker JW, Mellon M, Wald J, et al. A multiple-dosing, placebo-controlled study of budesonide inhalation suspension given once or twice daily for treatment of persistent asthma in young children and infants. Pediatrics. 1999;103:414-421.
  2. Data on file, DA-RES-26.