Using Omalizumab to Treat Allergic Asthma
The Efficacy and Safety of Omalizumab in the Treatment of Moderate to Severe Allergic Asthma:A Retrospective Single-center Clinical Trial
The First Affiliated Hospital with Nanjing Medical University · NCT06348407
This study is testing if omalizumab can help people aged 14 and older with moderate to severe allergic asthma feel better and manage their symptoms more effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years to 90 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University (other) |
| Drugs / interventions | omalizumab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06348407 on ClinicalTrials.gov |
What this trial studies
This study observes the efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with moderate to severe allergic asthma. It aims to gather data on how well the drug works and whether baseline clinical characteristics and biomarkers can predict treatment response and adherence. The study focuses on patients aged 14 and older who have a history of asthma exacerbations due to allergens and elevated IgE levels. The research is particularly relevant as omalizumab was recently introduced in mainland China, and local clinical data is still lacking.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 and older with moderate to severe allergic asthma who have a history of exacerbations and elevated IgE levels.
Not a fit: Patients with hypersensitivity to omalizumab or those experiencing an asthma exacerbation at baseline may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of omalizumab for managing allergic asthma in the Chinese population.
How similar studies have performed: Previous studies have shown success with omalizumab in treating allergic asthma, making this approach well-supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Moderate-to-severe asthma patients aged ≥ 14 years who met the criteria of the Asthma Group of the Chinese Thoracic Society (Guidelines for bronchial asthma prevention and management, 2020 edition)-moderate asthma was defined as those who could achieve complete control using grade 3 therapy, and severe asthma was defined as fully or incompletely controlled with grade 4 or 5 asthma medications. * History of asthma exacerbations induced by allergen exposure , elevated total serum IgE and positive specific IgE test or positive skin prick test. * Treatment with omalizumab. Exclusion Criteria: * Hypersensitivity to the active ingredient of omalizumab. * Asthma exacerbation in the baseline. * Combined with diseases that severely affect ventilation,such as bronchiectasis, lung cancer, allergic bronchopulmonary aspergillosis (ABPA), acute respiratory infections, chronic obstructive pulmonary disease (COPD),etc. * Receiving other biologically targeted therapies (e.g., anti-interleukin (IL)-5 monoclonal antibody, anti-IL-4 monoclonal antibody, anti-IL-13 monoclonal antibody, anti-IL-5 receptor α (IL-5Rα) monoclonal antibody, etc.)
Where this trial is running
Nanjing, Jiangsu
- Linfu zhou — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Linfu Zhou, Doctor
- Email: linfu.zhou@126.com
- Phone: 86+13611573618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Moderate to Severe Allergic Asthma, asthma, omalizumab, allergy, IgE