Moderate to severe allergic asthma
Conditions
Interventions
omalizumab a Treatment group:None
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 110 Years
Inclusion criteria
Inclusion criteria: (1) Moderate to severe allergic asthma aged =15 years in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Allergic Asthma and the Chinese Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 edition), and poorly controlled by conventional treatment with ICS/LABA or ICS/LABA/LAMA; (2) During screening, the serum total IgE concentration and body weight of the patient were within the dose range (60 IU/ml= serum total IgE concentration =1500 IU/ml, body weight between 20 Kg and 150 Kg); (3) For those who are currently ready to start omalizumab alpha therapy and whose benefits are expected to outweigh the risks, the previous IgE antibody use time must be =3 months from the current time, as assessed by clinicians; (4) Agree to participate in this study, be able to cooperate with follow-up, and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) The patient is in the period of acute asthma attack or acute exacerbation of asthma; (2) Pregnant or lactating women; (3) Severe liver and kidney function damage; Liver function: total bilirubin (TBIL) > 2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3×ULN Renal function: serum creatinine (Scr) > 1.5×ULN; (4) Patients with severe acute infection; (5) Allergic reaction to the active ingredient of the test drug or any other excipients; (6) Have a history of substance abuse, mental illness, or alcoholism and are unable to cooperate with clinical investigators; (7) Other patients deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in ACT scores from baseline at 24 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ACT scores from baseline at 16 weeks of treatment;OCS or/and ICS usage data at 16 and 24 weeks of treatment: total daily dose of OCS or/and ICS; Proportion of patients who stopped, decreased (did not stop), or increased OCS or/and ICS therapy compared to baseline;The number of acute asthma attacks at 16 weeks and 24 weeks were treated;Lung function (FEV1, FVC, and FEV1/FVC) improved from baseline at 16 and 24 weeks of treatment;Changes from baseline in investigator and patient overall evaluation of treatment effect (GETE) at 16 and 24 weeks of treatment;Changes from baseline in the asthma Quality of Life Questionnaire (AQLQ) at 16 and 24 weeks of treatment;Number and incidence of AEs; | — |
Countries
China
Contacts
Public ContactChen Yahong
Peking University Third Hospital
Outcome results
None listed