The Efficacy of Preseasonal Omalizumab Treatment
- Sponsor
- Beijing Tongren Hospital
- Study ID
- NCT04489121
- Status
- Completed
Conditions
- Seasonal Allergic Rhinitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Omalizumab — DRUGFor 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.
Study Details
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.
Key Dates
- Start date
- Jul 28, 2020
- Status verified
- Jan 2021
- Primary completion
- Sep 26, 2020
- Completion
- Oct 1, 2020
Study Design
- Enrollment
- 31 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: omalizumab preseasonal treatmentFor 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.
- No Intervention: controlNo preseasonal treatment was performed. Rescue medication could be used during pollen seasons.
Primary Outcome Measure
the change of total nasal symptoms scores [ Time Frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season). ]