Effects of omalizumab combined with budesonide formoterol on clinical efficacy, pulmonary function, immune function, and adverse reactions in children with moderate and severe allergic asthma

Allergol Immunopathol (Madr). 2023 Jul 1;51(4):182-188. doi: 10.15586/aei.v51i4.926. eCollection 2023.

Abstract

Objective: To evaluate the clinical efficacy and safety of combining omalizumab with budesonide formoterol to treat children with moderate and severe allergic asthma, and investigate the effect of this combination therapy on pulmonary and immune functions.

Methods: The data of 88 children with moderate and severe allergic asthma, who were admitted to our hospital between July 2021 and July 2022, were included in the study. The patients were randomly assigned either to control group (n = 44; received budesonide formoterol inhalation therapy) or experimental group (n = 44; received omalizumab subcutaneous injection + budesonide formoterol inhalation therapy) using computer-generated randomization. The clinical efficacy, asthma control (measured using childhood Asthma-Control Test [C-ACT] score), pulmonary function (forced expiratory volume in 1 s, forced vital capacity, and peak expiratory flow), immune function (cluster of differentiation 3 cells [CD3+ cells], cluster of differentiation 4 cells [CD4+ cells], immunoglobulin G, immunoglobulin A, and immunoglobulin E), and adverse reactions were observed and compared between both groups.

Results: After treatment, the experimental group had improved levels of pulmonary function and immune function indexes, higher C-ACT scores, and a higher overall response rate than the control group (P < 0.05). In addition, the incidence of adverse reactions was not significantly different between both groups (P > 0.05).

Conclusion: The combination of omalizumab with budesonide formoterol for treating moderate and severe allergic asthma in children demonstrated promising clinical efficacy and improved their pulmonary and immune functions, leading to more rational asthma control. The combined regimen demonstrated satisfactory clinical safety and deserved clinical promotion.

Keywords: allergic asthma; budesonide formoterol; immune function; omalizumab; pulmonary function.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Asthma*
  • Bronchodilator Agents / therapeutic use
  • Budesonide* / adverse effects
  • Budesonide, Formoterol Fumarate Drug Combination / therapeutic use
  • Child
  • Double-Blind Method
  • Ethanolamines / adverse effects
  • Forced Expiratory Volume
  • Formoterol Fumarate / therapeutic use
  • Humans
  • Immunity
  • Omalizumab / adverse effects
  • Treatment Outcome

Substances

  • Budesonide
  • Omalizumab
  • Bronchodilator Agents
  • Formoterol Fumarate
  • Ethanolamines
  • Budesonide, Formoterol Fumarate Drug Combination