Reduces Rescue ?₂-Agonist Use

PULMICORT RESPULES cut rescue medication use in half. Taking 0.25 mg twice daily over 12 weeks resulted in 48% fewer days of rescue ß₂-agonist use (6.0 days at the end of study from baseline 11.6 days), compared to 26% with placebo (P<.05 vs placebo).^4,6

Using rescue ß2-agonists more than twice a week is a sign of uncontrolled asthma

Study design^4,6

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 0.5-mg groups, respectively

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Asthma Guidelines

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Indication

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.

Important Safety Information

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.

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.

Please see accompanying full Prescribing Information (PDF).

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Reduces Rescue ?2-Agonist Use

Study design4,6