Active — Not RecruitingNot Applicable

Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma

China60 participantsStarted 2024-06-01

Plain-language summary

The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Chinese patients,aged 6 years and older，female or male
✓. Diagnosed as allergic asthma according to the guideline for Chinese guidelines for the diagnosis and treatment of allergic asthma（2019，the first edition）
✓. Meet the diagnostic criteria for moderate and severe asthma, in line with the diagnostic standards of the GINA (Global Initiative for Asthma)，it refers to those who can achieve complete control under the GINA Step 3 treatment; for severe asthma, it refers to those who need Step 4 or Step 5 treatment to achieve complete control, or those who still cannot achieve control even after undergoing Step 4 or Step 5 treatment.
✓. The patients included in the study were positive for specific immunoglobulin E (sIgE), or had a positive skin prick test (SPT) with D.pteronyssinus and D. farinae allergens.
✓. Patients who will initiate AIT or omalizumab combined with AIT according to real life clinical standards of practice.

Exclusion criteria

✕. Uncontrolled asthma or forced expiratory volume in one second (FEV1) is lower than 70% of the predicted value.
✕. Currently receiving treatment of beta blockers or angiotensin converting enzyme inhibitor (ACEI) 3．With severe or uncontrolled cardio-cerebral vascular, hepatic, renal, gastrointestinal, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study.

What they're measuring

the incidence rate of adverse reactions in standardized allergen immunotherapy

Timeframe: The observation time of this study is one year, starting from the time when the patient begins AIT therapy and followed up for one year.

Trial details

NCT IDNCT06771934

SponsorQianfoshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Allergic Asthma trials