Screening of predictive indicators of the efficacy of omalizumab in patients with moderate to severe refractory asthma

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100046343

Enrollment

Unknown

Registered

2021-05-14

Start date

2021-05-14

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma

Interventions

case series:Nil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Compliance with the diagnostic criteria of bronchial asthma prevention and treatment guideline 2020; 2.Volunteered to participate in the study and signed the informed consent; 3.Aged >=18 years, gender unlimited; 4.Serum IgE >= 60IU/ml; 5.Poor response to medium and high dose inhaled corticosteroids (400ug/d ~800ug/d)>= 4 weeks; 6.No serious heart, lung, brain, liver, kidney, blood system diseases; 7.Life expectancy is not less than 1 year.

Exclusion criteria

Exclusion criteria: 1. Women planning to become pregnant/lactating/pregnant; 2. Allergic to immunoglobulin or any ingredient of this product; 3. Have used immunomodulators or other immunotherapy within 1 month before enrollment; 4. Those who are unconscious or unable to cooperate; 5. Poor compliance, withdrawing halfway through.

Design outcomes

Primary

Measure	Time frame
eosinophil count in induced sputum;eosinophil count in blood;Lung function;Asthma Control Test (ACT);Inflammatory cytokines in blood;Inflammatory cytokines in sputum;3- bromotyrosine in urine;	—

Secondary

Measure	Time frame
Serum total IgE;Intestinal flora;	—

Countries

China

Contacts

Public ContactLiu Jing

the Fifth Affiliated Hospital of Sun Yat-Sen University

liujing25@sysu.edu.cn+86 13844021812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026