Allergic rhinitis
Conditions
Interventions
Test group:Lupatadine fumarate oral solution 1mg/ml, oral, body weight >=25kg: 5ml (5mg) once a day (calculated as lupatadine), 10kg=25kg: 5ml once a day, 10kg<=body weight<25kg: 2.5ml once a day, cou
Physiological seawater nasal treatment spray rinses the nasal cavity 2 times a day for 14 days.
Sponsors
Children's Hospital,Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. 2 years old = 10kg, male or female; 2. According to the 'Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children, 2022' , the diagnosis is confirmed, and the medical history is >= 1 year (chief complaint accepted), with at least one allergen and/or serum specific IgE positive in the skin prick test (allergen test report within 12 months of screening is acceptable); 3. The baseline reflex nasal symptom score (rTNSS score) has a total score of >= 24 points, with a "nasal congestion" score of 2 points <=total score <= 6 points (note: The baseline reflex nasal symptom score (rTNSS score) is obtained by recording continuous or discontinuous 4-day scale scores during the screening period. Those who do not obtain the 4-day rating data of the scale during the baseline period will be treated as screening failure; 4. The subjects and/or their guardians agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Individuals who are allergic to Lupatadine or any other ingredient in the drug (such as methylparaben, propylene glycol, etc.), known to be allergic to any antihistamines, or have a history of severe allergies; 2.Fructose intolerance, glucose galactose malabsorption, or insufficient sucrase isomaltase; 3.Known patients who have previously received regular antihistamines or combination therapy with two or more drugs with poor efficacy (regular medication is defined as: treatment with nasal hormones and antihistamines for no less than 2 weeks, treatment with leukotriene receptor antagonists for no less than 2 weeks, or a combination of the above drugs); 4.During the trial period, it is planned to use a combination of high-intensity and moderate CYP3A4 inhibitors (such as itraconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, nefazone, erythromycin, fluconazole, diltiazem), CYP3A4 sensitive substrates (such as simvastatin, lovastatin), CYP3A4 substrates with narrow treatment windows (such as cyclosporine, tacrolimus, sirolimus, everolimus, cisapride, etc.), grapefruit juice, ethanol, statins, and tricyclic antidepressants for a long time; 5.Individuals with clear QTc interval prolongation, uncorrectable hypokalemia, and poorly controlled arrhythmias such as bradycardia and acute myocardial ischemia; 6.During the trial period, it is planned to use other medications/non pharmacological treatments for allergic rhinitis besides the trial drug (such as inhaled, oral, intramuscular, intravenous sebum steroids, and potent or super potent topical sebum steroids); 7.Combining diseases/symptoms other than allergic rhinitis that may affect efficacy evaluation, such as respiratory diseases (severe bronchial asthma, pneumonia, etc.), rhinitis caused by other reasons (sinusitis requiring concomitant medication, non allergic rhinitis (such as infectious rhinitis, drug-induced rhinitis, etc.), nasal polyps, eye infections (such as infectious conjunctivitis, etc.), and other diseases that may interfere with efficacy evaluation; 8.The time for stopping medication before randomization did not meet the following criteria: Nasal use of sebum steroids: Discontinue medication for one week before randomization; Systemic use of sebum steroids: Discontinue medication for 4 weeks before randomization; Leukotriene receptor modulators: Discontinue medication for 4 weeks before randomization; Nasal tryptophan: Discontinue medication for 2 weeks before randomization; Nasal or systemic decongestants: Discontinue medication for 3 days before randomization; Nasal or systemic antihistamines: Discontinue medication for 3 days before randomization; Other drugs related to the treatment of allergic rhinitis not mentioned in this study need to be discontinued for at least 5 half lives or 7 days before randomization; 9.Individuals with abnormal liver function (such as ALT or AST exceeding the upper limit of normal by 1.5 times), abnormal kidney function (such as BUN or Cr exceeding the upper limit of normal by 1.5 times), abnormal 12 lead electrocardiogram with clinical significance determined by researchers, or other laboratory tests with clinical significance determined by researchers to be inappropriate for inclusion; 10.Cannot swallow oral medication or have a history of gastric or intestinal surgery that may interfere with drug absorption, distribution, metabolism, or excretion; 11.Not suitable for patients treated with nasal saline solution, su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the average rTNSS score within 14 days of treatment compared to the baseline 4-day average score.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean of individual symptoms (runny nose, nasal congestion, nasal itching, sneezing) scores in the reflex nasal symptom score (rTNSS score) within 7 days and 14 days of treatment from the mean of the 4-day baseline score;Changes in the average rTOSS score within 7 and 14 days of treatment compared to the baseline average score over 4 days;Changes in the average value of individual symptoms (itching, tearing, congestion) in the Reflective Eye Symptom Score (rTOSS) within 7 and 14 days of treatment compared to the baseline 4-day averag;Overall impression of therapeutic effect after 7 and 14 days of treatment;After 7 days and 14 days of treatment, the total score and individual scores of RQLQ (children's version) changed from baseline;Percentage of subjects using salvage medication;Time to onset of drug; | — |
Countries
China
Contacts
Public ContactYong Fu
Children's Hospital,Zhejiang University School of Medicine
Outcome results
None listed