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

Active, not recruitingOBSERVATIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Allergic Asthma
Interventions
BIOLOGICAL

Allergen-specific immunotherapy(AIT)

"Allergen-Specific Immunotherapy(AIT) Protocol: using the house dust mite allergen preparation (Alutard, ALK Company, Denmark). The treatment course was divided into the initial treatment stage and the maintenance treatment stage. The initial treatment stage, also known as the dose accumulation stage, involved injecting the vaccine once a week and usually lasted for 15 weeks. For highly sensitive patients, treatment was carried out according to the dose guidelines for high sensitivity. The maximum dose in the initial treatment stage was the maintenance dose. After reaching the maintenance dose, the first maintenance injection was given 2 weeks later, the second maintenance injection was given 4 weeks later, and thereafter, a vaccine injection was carried out every 4 - 8 weeks."

BIOLOGICAL

omalizumab

Omalizumab Treatment Protocol: The dosage and administration frequency (once every 2 weeks or once every 4 weeks) of omalizumab were determined based on the patients' pretreatment serum total IgE (kU/L), age, and body weight (kg). Each dosage ranged from 15 to 600 mg and was administered subcutaneously. If the dosage was ≤ 150 mg, it was injected subcutaneously at 1 site; otherwise, it was injected subcutaneously at 1 to 4 sites respectively. After the first 3 injections, patients were observed in the hospital for at least 2 hours, and after the 4th and subsequent injections, they were observed for at least 30 minutes. During the treatment period, the background medications for asthma control were adjusted according to the patient's condition.

Trial Locations (1)

250014

Shandong Provincial Qianfoshan Hospital,The First Affliated Hospital of Shandong First Medical University, Jinan

All Listed Sponsors
lead

Qianfoshan Hospital

OTHER

NCT06771934 - Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma | Biotech Hunter | Biotech Hunter