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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Page 1 of 1 (1 locations)

1

Linfu zhou

Nanjing, Jiangsu, China, 210000

A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE) | DecenTrialz