The Efficacy of Preseasonal Omalizumab Treatment

NCT ID: NCT04489121

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2020-10-01

Brief Summary

Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR).

In recent years, biologics have become promising drugs for allergic diseases. The efficacy and safety of Omalizumab in treating SAR have been well proven by previous studies. However, the efficacy in preseasonal treatment for SAR has not yet been studied before.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

omalizumab preseasonal treatment

For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season. Rescue medication could be used during pollen seasons.

Group Type: EXPERIMENTAL

Omalizumab

Intervention Type: DRUG

For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.

control

No preseasonal treatment was performed. Rescue medication could be used during pollen seasons.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Omalizumab

For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female outpatients aged 18 to 60 years (inclusive).
• With history of SAR for at least two years, with/without conjunctivitis and without asthma
• Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
• Sensitised to common autumn pollens including sagewort and ragweed (a specific IgE level ≥ 3.5 kU/L).
• Patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
• Patients who are able to understand the information given and the consent and complete the daily record card.

Exclusion Criteria

• Patients with oral diseases/ allergies within the run-in period.
• Patients accepted any kind of operations within 4 weeks of the run-in period.
• Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
• Patients with PAR.
• Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
• Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
• patients with comorbidity of severe asthma.
• Patients applying beta-antagonist (local or systemic appliance).
• Pregnant, breast-feeding / sexually active women of childbearing potential.
• Patients treated with AIT for pollens within 3 years.
• Participation in any clinical study within the 3 months of the run-in period.
• Patients at risk of non-compliance..
• Patients with immunologic suppression, diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luo Zhang

President, Beijing TongRen Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luo Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Preseasonal-OMA-AR

Identifier Type: -

Identifier Source: org_study_id