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PULMICORT RESPULES significantly reduces daytime and nighttime asthma symptoms1,2

In pivotal clinical trials, PULMICORT RESPULES significantly improved daytime and nighttime asthma symptoms, significantly reduced reliance on breakthrough medication and improved lung function in patients capable of performing lung function testing.

Daytime Asthma Symptoms Chart

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Nighttime Asthma Symptoms Chart

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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.

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.

Among more than 340 children aged 12 months to 8 years, Kemp and colleagues showed that once daily PULMICORT RESPULES significantly1:

  • Decreased daytime asthma symptom scores
  • Decreased nighttime asthma symptom scores
  • Reduced the use of short-acting ß2-agonists
  • Improved FEV1 in the 0.5 mg and 1.0 mg treatment groups among patients capable of performing lung function testing
  • Did not result in significant differences in basal of ACTH-stimulated cortisol levels

Study Design

  • Multicenter, double-blind, placebo-controlled, parallel-group study to determine efficacy and safety of once-daily doses of PULMICORT RESPULES
  • 343 pediatric patients (12 months to 8 years of age) with mild persistent asthma randomized to receive 0.25 mg, 0.5 mg, 1 mg, or placebo for 12 weeks
  • Daytime and nighttime asthma symptoms were rated on a 4-point scale: 0 = none; 1 = mild (awareness of asthma symptoms that were easily tolerated); 2 = moderate (asthma symptoms with some discomfort, causing some interference of sleep or daily activities); 3 = severe (incapacitating asthma symptoms, with inability to sleep or perform daily activities)
  • Over the 12-week period, mean change from baseline in daytime asthma symptom scores was –0.25, –0.58, –0.46, and –0.53 in placebo, 0.25-mg, 0.50-mg, and 1.0-mg groups, respectively, correlating to an overall mean reduction of 20%, 40%, 35%, and 40%, respectively
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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 (PDF).]

References

  1. Kemp JP, Skoner DP, Szefler SJ, et al. Once-daily budesonide inhalation suspension for the treatment of persistent asthma in infants and young children. Ann Allergy Asthma Immunol. 1999;83:231-239.
  2. Data on file, DA-RES-04.