Status:
UNKNOWN
A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE)
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Moderate to Severe Allergic Asthma
Eligibility:
All Genders
14-90 years
Brief Summary
Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of ...
Eligibility 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.)
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06348407
Start Date
December 1 2023
End Date
November 30 2024
Last Update
April 4 2024
Active Locations (1)
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1
Linfu zhou
Nanjing, Jiangsu, China, 210000