This is a prospective study. It enrolls subjects with allergic rhinitis, with or without asthma, who have nasal congestion as the main symptom and meet the inclusion criteria, aiming to evaluate the efficacy and safety of acoustic vibration combined with an oscillating positive expiratory pressure device in the treatment of patients with nasal congestion. On the premise that subjects agree to use basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA), they are instructed to use the acoustic vibration therapy device and the oscillating positive expiratory pressure therapy device respectively, 3 times a day for 3 minutes each time. Indicators related to nasal congestion will be measured immediately after a single use, as well as at 2 weeks, 4 weeks, and 8 weeks of use, so as to monitor the improvement of nasal ventilation and accompanying symptoms in the subjects.
Subjects aged 12-50 years at the time of signing the informed consent form, regardless of gender; Meeting the guideline diagnostic criteria for allergic rhinitis with or without asthma; Presenting with significant nasal congestion for at least 1 week, with or without asthma, and symptoms poorly controlled despite the use of intranasal glucocorticoids and/or other therapeutic drugs; Patients with moderate to severe seasonal allergic rhinitis (SAR) with a mean Total Nasal Symptom Score (TNSS) ≥ 9 points, including nasal congestion ≥ 3 points; Willing and able to complete follow-up visits and scoring assessments at 2 weeks, 4 weeks, and 8 weeks during the study period as required by the protocol; Regular use of standard medications; Willing to receive treatment with acoustic vibration or oscillating positive expiratory pressure device 3 times a day for 3 minutes each time, and perform corresponding check-in and reporting; Voluntarily signing the informed consent form before the start of any study-related procedures, able to communicate smoothly with researchers, understand and be willing to strictly comply with the requirements of this clinical study protocol to complete the study.
Exclusion criteria identified by pre-examination with nasal endoscopy include: definite structural/mechanical obstruction (moderate-to-severe nasal septum deviation, moderate-to-severe nasal valve collapse, grade 3-4 nasal polyps, and inferior turbinate hypertrophy that may reduce decongestion reversibility); A history of severe epistaxis within 3 months, or use of anticoagulants; Complicated with unstable asthma; Patients currently receiving special treatment regimens, including biologic therapy and dust mite desensitization therapy; Complicated with major diseases of the respiratory or cardiovascular system: such as moderate-to-severe COPD, coronary heart disease, bronchiectasis, pulmonary infection, or respiratory tract infection; Suffering from malignant tumors or having a history of malignant tumors (except for cutaneous squamous cell carcinoma, basal cell carcinoma, or cervical carcinoma in situ that have been completely resected with no evidence of recurrence); Having undergone major surgery within 3 months before randomization, or planning to undergo major surgery during the study period; Suffering from severe concomitant diseases or other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this trial.
Parallel
VPAT (Vibratory Positive Pressure Therapeutic Apparatus）
DeviceVPAT (Vibratory Positive Pressure Therapeutic Apparatus）is a physical solution which can relieve nasal congestion and discomforts by applying acoustic vibration and oscillatory positive expiratory pressure. Clinical research has shown that low-frequency vibration at approximately 130 Hz promotes the production of the highest concentration of Nitric Oxide (NO) in the paranal sinuses, which helps to regulate the nasal mucosal blood, restoring the mucous membrance-cilia mechanism, clean up the bacteria, viruses and allergenic particles in the respiratory tract. Combined with Oscillatory Positive Expiratory Pressure and Transnasal Breathing, it can help to cultivate the habit of nasal breathing and slow breathing, as well as to restore the function of lungs.
basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA
DrugAll participants need basic control drugs contains antihistamines(Ebastine 10 mg once daily for 2 weeks), mometasone furoate nasal spray(Spray 2 puffs into each nostril, each puff contains 50 μg of mometasone furoate, i.e., 100 μg per administration, once daily for 2 weeks). Asthma participants should added Inhaled corticosteroids-long-acting beta-agonists (ICS-LABA) therapy. For mild to moderate asthma: budesonide/formoterol (160μg/4.5μg) , with 1 inhalation each time, twice daily, or salmeterol/fluticasone propionate (50μg/100μg) with 1 inhalation each time, twice daily. For moderate to severe asthma: Budesonide/Formoterol (320μg/4.5μg), with 1 inhalation each time, twice daily; or salmeterol/fluticasone propionate (50μg/250μg or 50μg/500μg) with 1 inhalation each time, twice daily. Dosage adjustments should be evaluated and determined by the physician based on the patient's disease control status.
OPEP（Oscillating Positive Expiratory Pressure device）
DeviceOscillating Positive Expiratory Pressure (OPEP) device contain a inner ball that creates a resistance and oscillates when the patient blows through the device. This resistance helps splint the airways open during exhalation whilst the oscillation loosens the mucous within the airways. This makes it easier for some patients to clear their sputum.
Peak Nasal Inspiratory Flow (PNIF)
PNIF is a simple, portable inspiratory flow meter, which measures PNIF (peak nasal inspiratory flow) through the nasal passage; providing information of nasal obstruction. Objective measurement of nasal obstruction is useful in the diagnosis of a number of conditions and establishing efficacy of nasal decongestants, it can be Individually calibrated and used during assessment of allergic rhinitis.
Peak Expiratory Flow (PEF)
VAS (Visual Analogue Scale )
Total Nasal Symptom Score + Total Non-Nasal Symptom Score (TNSS + TNNSS)
RQLQ(Rhinitis-Related Quality of Life Questionnaire )
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Huzhou Central Hospital
Collaborator
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
First People's Hospital of Hangzhou
Collaborator
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