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Updated: Jan 9, 2026
A Traditional Chinese Medicine Characteristic Therapy for Bronchial Asthma: Moxibustion
Published on: May 12, 2023
Benefits of CMAB007 in Chinese Patients Having Inadequately Controlled Moderate/Severe Asthma With Increased Total
Kefang Lai1,2, Zhijun Yan3, Donghua Qian4
1State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Purpose:
The objective of this trial was to evaluate the efficacy and safety of anti-IgE monoclonal antibody (CMAB007) in Chinese patients with inadequately controlled moderate or severe asthma with increased total IgE level despite medium or high dose inhaled corticosteroids (ICS)/long acting β₂-agonist (LABA) treatment.
Methods:
This was a multicenter, randomized, placebo controlled, double blinded, phase 3 trial. Eligible patients with moderate or severe asthma with increased total IgE level (60-1,500 IU/mL) receiving optimal ICS-LABA were randomly assigned to receive CMAB007 or placebo treatment at a 2:1 ratio for 24 weeks. The primary efficacy endpoint was asthma exacerbation (AE) rate, the key second endpoints were asthma control test (ACT) score, pulmonary function and safety.
Results:
A total of 392 patients were included in the efficacy analysis. AE rate was 0.45 with CMAB007 and 0.66 with placebo (hazard ratio, 0.68; 95% confidence interval, 0.49, 0.96; P = 0.030). The proportions of patients showing an increase of at least 3 points from baseline in ACT scores were greater in the CMAB007 group than in the placebo group at Week 8 (49.8% vs. 36.9%, P = 0.018), Week 16 (59.4% vs. 42.9%, P = 0.003) and Week 24 (60.2% vs. 47.0%, P = 0.019). Greater improvement of pre-bronchodialteor forced expiratory volume in 1 second was achieved in the CMAB007 group at 4 weeks (11.40% vs. 5.03%, P = 0.006), 8 weeks (16.27% vs. 6.57%, P = 0.003), 12 weeks (16.51% vs. 6.60%, P = 0.002) and 16 weeks (20.18% vs. 7.42%, P = 0.002). The incidence of adverse events was similar between the CMAB007 (77.2%) and placebo groups (75.2%).
Conclusions:
CMAB007 reduces AE and improves asthma control, lung function and quality of life without additional safety concern in Chinese patients having moderate to severe asthma with increased total IgE level.
Trial Registration:
ClinicalTrials.gov Identifier: NCT03468790.
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