Effect of nebulized beclomethasone on airway inflammation and clinical status of children with allergic asthma and rhinitis: a randomized, double-blind, placebo-controlled study

Int Arch Allergy Immunol. 2013;161(1):53-64. doi: 10.1159/000343137. Epub 2012 Dec 14.

Abstract

We aimed to evaluate the therapeutic effect of nebulized beclomethasone dipropionate (nBDP) on both allergic asthma and rhinitis. In a randomized, double-blind, placebo-controlled study, 40 children (mean age 10.7 ± 2.1 years) with allergic asthma and rhinitis received either nBDP (daily dose of 800 µg, administered twice daily) or placebo for 4 weeks (with a face mask), after a 2-week run-in period of clinical assessment. Nasal and oral fractional exhaled nitric oxide (FeNO) measurements together with pulmonary function tests, nasal and oral exhaled breath condensate (EBC) collection for pH and interleukin-5 (IL-5) measurements as well as nasal and bronchial symptom scores were obtained at baseline and after 4-week treatment. A significant improvement in oral FeNO, oral and nasal EBC IL-5 and nasal EBC pH was observed in the nBDP group when comparing the values with baseline, together with an improvement in symptom score of the visual analogue scale, nasal obstruction, sneezing, rhinorrhea, breathing difficulty, cough, wheezing and sleep disturbance (nBDP end treatment vs. baseline, Wilcoxon signed-rank test). nBDP was more effective than placebo (ANCOVA test) in improving [difference Δ = response after treatment at the last visit (active or placebo) - value at baseline] nasal pH, oral IL-5, oral FeNO, forced expiratory volume in 1 s, forced expiratory volume in 1 s/forced vital capacity, peek expiratory flow, visual analogue scale, breathing difficulty, cough, wheezing and sleep disturbance scores. No differences were observed between the nBDP and the placebo group for symptom score of rhinitis. nBDP is a useful treatment for airway inflammation and clinical status in children with concomitant allergic asthma and rhinitis.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adrenergic beta-2 Receptor Agonists / administration & dosage
  • Anti-Asthmatic Agents / administration & dosage*
  • Asthma / drug therapy*
  • Asthma / metabolism
  • Asthma / physiopathology
  • Beclomethasone / administration & dosage*
  • Breath Tests
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin E / blood
  • Interleukin-5 / metabolism
  • Male
  • Nebulizers and Vaporizers
  • Nitric Oxide / metabolism
  • Pilot Projects
  • Respiratory Function Tests
  • Rhinitis, Allergic, Perennial / drug therapy*
  • Rhinitis, Allergic, Perennial / metabolism
  • Rhinitis, Allergic, Perennial / physiopathology

Substances

  • Adrenergic beta-2 Receptor Agonists
  • Anti-Asthmatic Agents
  • Interleukin-5
  • Nitric Oxide
  • Immunoglobulin E
  • Beclomethasone