perennial allergic rhinitis
Conditions
Interventions
Standard dose group:Omalizumab for injection
Precision dosing group:Omalizumab for injection
Conventional treatment group:Mometasone Furoate Nasal Spray (MFNS) and Loratadine
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 65 years, regardless of gender. 2) Confirmed diagnosis of Perennial Allergic Rhinitis (PAR), defined as a history of at least 1 year, symptoms lasting for more than 8 weeks each year, and symptoms lasting for more than 2 hours per day. 3) At the time of screening, subjects must have a positive skin prick test to one or more perennial allergens (excluding animal dander) including dust mites, or a positive specific IgE in serum (>= 0.70 kU/L). 4) During the study period, subjects must be continuously exposed to at least one perennial allergen to which they have a positive skin prick test. 5) Subjects must have clinical symptoms associated with the perennial allergen that is positive on skin prick test or serum specific IgE test. 6) Use of mometasone furoate nasal spray or other treatments for PAR with poor control of PAR symptoms or unsatisfactory subjective symptom control as reported by the subject. 7) Must meet the following criteria simultaneously: - At screening, the iTNSS score is >= 6. - On the morning of the baseline visit before medication, the iTNSS score is >= 6. - At baseline, the rTNSS is >= 6, with nasal congestion >= 2, and at least one of the symptoms of rhinorrhea, nasal itching, and sneezing >= 2. 8) Subjects with coexisting asthma must have stable asthma for at least 1 month prior to screening while receiving permitted standard asthma treatment. 9) Willing to participate and sign the informed consent form, and able to comply with all examinations and follow-ups.
Exclusion criteria
Exclusion criteria: 1) Use of anti-IgE drugs or other biologics targeting IgE or the Th2 pathway (e.g., omalizumab and its biosimilars, anti-IL-4/5/13 monoclonal antibodies) within 5 half-lives prior to obtaining informed consent. 2) Use of systemic immunosuppressants (e.g., methotrexate, cyclosporine, cyclophosphamide, tacrolimus, tripterygium glycosides). 3) Allergy to omalizumab, excipients of the treatment drugs, or other biosimilars, or a history of severe drug allergy or anaphylactic shock. 4) Contraindications to or intolerance of mometasone furoate or any background medications to be used during the study period. 5) Patients with total IgE 1,500 U/ml, or body weight 150 kg. 6) Elevated IgE levels due to causes other than allergens. 7) Patients experiencing an acute asthma exacerbation or acute worsening of asthma. 8) Patients with asthma who meet any of the following criteria should be excluded: - Forced expiratory volume in 1 second (FEV1) = 2 severe asthma exacerbations in the past year, defined as any asthma worsening requiring systemic corticosteroid treatment for at least 3 days and/or hospitalization. A single episode of corticosteroid administration via parenteral route due to asthma worsening is also considered a severe exacerbation. - Use of mometasone furoate nasal spray at a daily dose higher than 400 µg or an equivalent inhaled corticosteroid (ICS). 9) Patients with acute sinusitis, concurrent acute nasal infection, or upper respiratory tract infection. 10) Patients who have undergone any nasal or sinus surgery within 1 year prior to screening. 11) Patients with a history of rhinitis secondary to other causes (e.g., drug-induced rhinitis, vasomotor rhinitis). 12) Patients with active or acute infections requiring treatment with systemic antibiotics, antiviral agents, antiparasitic drugs, antiprotozoal agents, or antifungal agents within 2 weeks prior to baseline. 13) Patients with clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematologic, or neurological diseases, or a family history of congenital immunodeficiency or use of immunosuppressive or anti-inflammatory therapy within the past 6 weeks. 14) Patients with severe hepatic or renal impairment, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN), total bilirubin > 1.5 times ULN, or serum creatinine > 1.2 times ULN. 15) Patients with autoimmune hepatitis, a history of hepatitis C, or hemoglobinopathies (e.g., thalassemia major, sickle cell anemia). 16) Patients with a history of malignancy in any organ system within 5 years prior to screening, regardless of evidence of local recurrence or metastasis (excluding basal cell carcinoma that has been treated and shows no signs of recurrence within the past 12 weeks, actinic keratosis, or Bowen disease [squamous cell carcinoma in situ]; 1.cervical carcinoma in situ or non-invasive malignant colorectal polyps that have been surgically removed and show no signs of recurrence within the past 5 years). 17) Patients with psychiatric disorders or cognitive impairment who are unable to understand and comply with the study protocol. 18) Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study period. 19) Women of childbearing potential and/or men and their partners who refuse to use highly effective (for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Nasal Symptom Scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Incidence and severity of adverse events;nNO;serum total IgE;?Total Nasal Symptom Scores;Nasal resistance measurement;Nasal secretions;Total Ocular Scoring System;Serum cytokines; | — |
Countries
China
Contacts
Public ContactXicheng Song
Yantai Yuhuangding Hospital
Outcome results
None listed