Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids

Ann Allergy Asthma Immunol. 2001 Jun;86(6):633-40. doi: 10.1016/S1081-1206(10)62291-0.


Background: The incidence of pediatric asthma has increased dramatically over the past few decades, with approximately 5% of American children affected by the disease.

Objectives: To compare the efficacy and safety of once-daily budesonide Turbuhaler with placebo in asthmatic children previously treated with orally inhaled corticosteroids.

Methods: This randomized, double-blind, placebo-controlled, multicenter (17 centers) study included 274 male and female children (aged 6 to 17 years) with a history of asthma for at least the previous 6 months. Patients received placebo or budesonide Turbuhaler (200 microg or 400 microg) once daily for 12 weeks. Efficacy variables included mean changes from baseline in forced expiratory volume in 1 second (FEV1), AM and PM peak expiratory flow rates (PEFRs), nighttime and daytime asthma symptom severity scores, patient discontinuations, use of beta2-agonists as breakthrough medication, forced vital capacity (FVC), and midexpiratory flow rate between 25% and 75% of FVC (FEF25%-75%). Safety was evaluated by adverse events, physical examinations, vital signs, and laboratory tests.

Results: Baseline characteristics were comparable among treatment groups. Percentage of predicted FEV1 at baseline was 76.6 +/- 6.9 for placebo, 77.5 +/- 7.1, and 77.0 +/- 7.8 for the budesonide Turbuhaler 200 microg and 400 microg groups, respectively. Significantly (P < or = 0.024) more placebo patients (24%) discontinued treatment because of disease deterioration or no improvement than budesonide Turbuhaler 200 microg (11%) or 400 microg patients (10%). Patients receiving budesonide Turbuhaler experienced significant improvements in FEV1 compared with patients receiving placebo (P < or = 0.015). Significant (P < or = 0.041) improvements over placebo also were observed in AM and PM PEFRs, FVC, FEF25%-75%, nighttime and daytime asthma symptoms, and amount of beta2-agonist used in both budesonide Turbuhaler groups. Adverse events were generally mild or moderate in intensity and similar among treatment groups.

Conclusions: Once-daily budesonide Turbuhaler is effective and safe in children with persistent asthma previously maintained on at least twice-daily dosing regimens of inhaled corticosteroids.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / therapeutic use*
  • Budesonide / administration & dosage*
  • Budesonide / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Middle Aged
  • Peak Expiratory Flow Rate


  • Anti-Inflammatory Agents
  • Budesonide