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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
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.
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
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).
Rescue medication score
when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication. The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)
Time frame: at week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
the change of quality of life
mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)
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).
adverse events
Any adverse event following injection was assessed by physicians and patients. Patients in the Omalizumab group are instructed to record any unexpected signs, symptoms, and feelings during the subcutaneous injection of Omalizumab.
Time frame: one hour after injection in the Omalizumab group
eosinophilic indicators in nasal secretions
The level of eosinophilic indicators; Charcot-Leyden crystal (CLC) , Cystatin SN
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).
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