Dose-related efficacy of budesonide administered via a dry powder inhaler in the treatment of children with moderate to severe persistent asthma,☆☆,,★★,

https://doi.org/10.1016/S0022-3476(98)70394-4Get rights and content

Abstract

Objective: To determine the efficacy and safety of budesonide delivered by an inhalation-driven dry powder inhaler (Turbuhaler) in children with moderate to severe persistent asthma. Study design: In our randomized, double-blind, placebo-controlled, parallel-group, multicenter study, a total of 404 children with asthma, who were aged 6 to 18 years and who had been receiving inhaled glucocorticosteroid therapy, were randomly assigned to receive either 100, 200, or 400 μg of budesonide or placebo twice daily for 12 weeks. At baseline, mean forced expiratory volume in 1 second (FEV1) was 74.6% (range, 30.7% to 123.3%) of the predicted normal value. Results: Patients in each of the three budesonide treatment groups showed significant dose-related improvements in lung function (morning peak expiratory flow and FEV1), in asthma symptoms, and with a significant decrease in inhaled β2-agonist use in comparison with placebo. Improvements were evident within 2 weeks and were maintained throughout the 12 weeks. Budesonide treatment had no significant effect on hypothalamic–pituitary–adrenal axis function, and the incidence of reported adverse events was similar in all treatment groups. Conclusion: Budesonide administered via a dry powder inhaler provided dose-related improvements in lung function and clinical status and was well tolerated by children (6 to 18 years of age) with moderate to severe persistent asthma. (J Pediatr 1998;132:976-82.)

Section snippets

Subjects

Pediatric subjects with a minimum history of 6 months of inhaled GCS-dependent asthma with perennial symptoms were enrolled into the study at 25 centers in the United States. To be eligible for inclusion, patients had to be aged 6 to 18 years and to have had reversible airway obstruction at the screening visit, defined by a 15% increase in forced expiratory volume in 1 second after inhalation of 180 or 360 μg of the β2-agonist albuterol (Proventil). In addition, an FEV1 of 50% or greater, and

Subjects

Children (314 boys and 90 girls) were randomly selected, and 305 of the 404 subjects completed the double-blind period. Baseline screening characteristics were comparable between the four treatment groups (Table I). Subjects in all four groups had a comparable range of mean percentage of predicted FEV1 (75%), and of morning PEF values at baseline, as well as comparable use of β2-agonists (Tables I and II).

. Baseline characteristics: All patients

Empty CellEmpty CellBudesonide (μg bid)
CharacteristicPlacebo100200400

DISCUSSION

The data presented in this report are relevant to the ongoing development of optimal guidelines for asthma management.3, 13 These and other guidelines have identified the need for an increased level of asthma control. The more aggressive goals for treatment of asthma have also resulted in an increased use of inhaled GCS in mild to moderate persistent asthma in children. However, there are few data in children to support the recommended use of individual dose-titration when inhaled GCS is used.

References (16)

  • S Pedersen et al.

    Budesonide treatment of moderate and severe asthma in children: a dose-response study

    J Allergy Clin Immunol

    (1995)
  • PJ Barnes

    Inhaled glucocorticoids for asthma

    N Engl J Med

    (1995)
  • W Busse et al.

    Childhood- versus adult-onset asthma

    Am J Respir Crit Care Med

    (1995)
  • Guidelines for the diagnosis and management of asthma

    (1992)
  • Å Ryrfeldt et al.

    Pharmacokinetics and metabolism of budesonide, a selective glucocorticoid

    Eur J Respir Dis

    (1982)
  • L Thorsson et al.

    Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI

    Eur Respir J

    (1994)
  • RN Brogden et al.

    Budesonide: an updated review of its pharmacological properties, and therapeutic efficacy in asthma and rhinitis

    Drugs

    (1992)
  • K Dahlstrom et al.

    Rectal pharmacokinetics of budesonide

    Eur J Clin Pharmacol

    (1996)
There are more references available in the full text version of this article.

Cited by (111)

  • The safety of long-term use of inhaled corticosteroids in patients with asthma: A systematic review and meta-analysis

    2022, Clinical Immunology
    Citation Excerpt :

    The P value of Begg's rank correlation test (STATA 12.0) was used to assess the presence of publication bias in included articles for each outcome. Of 17,234 trials recognized by the initial search, 331 were retrieved for more detailed assessment, and 86 trials [8–91,105–107] were included in the meta-analysis (Fig. 1). Baseline characteristics of trials included in the meta-analysis are shown in Table 1.

  • Asthma in Older Children: Special Considerations

    2016, Pediatric Allergy: Principles and Practice: Third Edition
  • Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma

    2015, Annals of Allergy, Asthma and Immunology
    Citation Excerpt :

    Results of safety analyses did not show any concerns for the doses tested, and no serious AEs were reported. Importantly, the safety profile was similar to the known safety profile of budesonide in other formulations and devices when studied in children 6 to younger than 12 years.3,4,12 As in the present study, common AEs reported in studies with budesonide administered by dry-powder inhaler and nebulizer were respiratory infections (eg, sinusitis, rhinitis, pharyngitis).4,12

  • Inhaled corticosteroid dosing: Double for nothing?

    2011, Journal of Allergy and Clinical Immunology
View all citing articles on Scopus

From the Carolina Allergy and Asthma Consultants, Raleigh, North Carolina; the Pediatric Allergy Association, West Hartford, Connecticut; Colorado Asthma and Allergy, Aurora, Colorado; the Allergy and Asthma Rochester Resource Center, Fairport, New York; and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado.

☆☆

Supported by a grant from Astra, USA. All authors have had research funded through grants from Astra, USA, and have had consultant roles with Astra, USA.

Reprint requests: Gail Shapiro, MD, 4540 Sand Point Way, NE, Suite 200, Seattle, WA 98105.

★★

*See Appendix.

0022-3476/98/$5.00 + 0 9/21/88763

View full text