Efficacy


The efficacy of PULMICORT RESPULES has been established in well-controlled clinical trials.2,3


Reduces nighttime and daytime asthma symptoms


In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 343 pediatric patients (12 months to 8 years of age) with mild, persistent asthma were randomized to receive PULMICORT RESPULES 0.25 mg, 0.5 mg, 1 mg, or placebo for 12 weeks. Nighttime and daytime 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 with sleep or daily activities); 3=severe (incapacitating asthma symptoms, with inability to sleep or perform daily activities).4


Nighttime

  • Up to a 38% reduction in nighttime asthma symptoms from baseline, sustained over 12 weeks (placebo, 14% reduction)3
    • 0.25 mg once daily: 37% reduction from baseline (adjusted mean change from baseline [-0.49]/baseline [1.34]); P=.001 vs placebo
    • 0.5 mg once daily: 34% reduction from baseline (adjusted mean change from baseline [-0.41]/baseline [1.19]); P=.01 vs placebo
    • 1 mg once daily: 38% reduction from baseline (adjusted mean change from baseline [-0.45]/baseline [1.18]); P≤.01 vs placebo
    • Placebo: 14% reduction from baseline (adjusted mean change from baseline [-0.15]/baseline [1.07])

Daytime

  • Up to a 40% reduction in daytime asthma symptoms from baseline, sustained over 12 weeks (placebo, 20% reduction)3
    • 0.25 mg once daily: 40% reduction from baseline (adjusted mean change from baseline [-0.58]/baseline [1.46]); P=.001 vs placebo
    • 0.5 mg once daily: 35% reduction from baseline (adjusted mean change from baseline [-0.46]/baseline [1.33]); P≤.05 vs placebo
    • 1 mg once daily: 40% reduction from baseline (adjusted mean change from baseline [-0.53]/baseline [1.31]); P<.01 vs placebo
    • Placebo: 20% reduction from baseline (adjusted mean change from baseline [-0.25]/baseline [1.26])

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.2

PULMICORT RESPULES is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.2

The evidence supports the efficacy of the same nominal dose of
PULMICORT RESPULES administered on either a once-daily or twice-daily schedule. However, when all measures are considered together, the evidence is stronger for twice-daily dosing.2

Adverse reactions that occurred at a rate of ≥ 3% are: respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, and rash.

Among 343 children aged 12 months to 8 years with mild, persistent asthma, Kemp and colleagues showed that once-daily PULMICORT RESPULES significantly3,4

  • Decreased nighttime asthma symptom scores
  • Decreased daytime asthma symptom scores
  • Reduced the use of short-acting rescue β2-agonists

Reduces use of rescue β2-agonists

In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 178 pediatric patients (4 to 8 years of age) were randomized to receive
PULMICORT RESPULES 0.25 mg, 0.5 mg, 1 mg, or placebo twice daily. Over the 12-week period, rescue β2-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.5,6


PULMICORT RESPULES cut rescue medication use in half. Taking 0.25 mg twice daily over 12 weeks resulted in 48% fewer days of rescue β2-agonist use (6.0 days at the end of study from baseline 11.6 days), compared to 26% with placebo (P<.05 vs placebo).5,6


PULMICORT RESPULES (budesonide inhalation suspension) evaluated by need for rescue medication 3 5,6

IMPORTANT SAFETY INFORMATION ABOUT PULMICORT RESPULES


PULMICORT RESPULES 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 RESPULES, because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

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.

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

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

Hypersensitivity reactions, including anaphylaxis, have been reported with budesonide.

As with other inhaled medications, paradoxical bronchospasm may occur with
PULMICORT RESPULES.

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions and clinical features consistent with Churg-Strauss Syndrome.

Adverse reactions that occurred at a rate of ≥ 3% are: respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, and rash.


Indication


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

Please click here for full Prescribing Information for PULMICORT RESPULES.