Atopic Asthma, Atopic Rhinitis
Conditions
Keywords
nasal congestion, Vibroacoustic therapy, Oscillating Positive Expiratory Pressure
Brief summary
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.
Detailed description
Objective: 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. Methods: A total of 200 subjects with nasal congestion as the main symptom who met the inclusion criteria were enrolled in this study. Among them, 100 subjects were treated with an acoustic vibration therapy device (treatment group), including 50 subjects with allergic rhinitis and 50 subjects with allergic rhinitis complicated with asthma; the other 100 subjects were treated with an oscillating positive expiratory pressure therapy device (without acoustic function, only with oscillating positive expiratory pressure function) as the control group, which also included 50 subjects with allergic rhinitis and 50 subjects with allergic rhinitis complicated with asthma. On the premise that subjects agreed to use basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA), they were instructed to use the acoustic vibration therapy device or the oscillating positive expiratory pressure therapy device, respectively, 3 times a day for 3 minutes each time. Nasal congestion-related indicators were measured immediately after a single use, as well as at 2 weeks, 4 weeks, and 8 weeks of use. The improvement of nasal ventilation and accompanying symptoms was monitored to clarify the efficacy and safety of the two devices. Key Inclusion Criteria: 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. Expected Outcomes: Statistically significant improvements in relevant parameters in the oscillating positive expiratory pressure therapy device group after treatment, including: Peak Nasal Inspiratory Flow (PNIF), Peak Expiratory Flow (PEF), Fractional Exhaled Nitric Oxide(FeNO), Visual Analogue Scale (VAS), Total Nasal Symptom Score + Total Non-Nasal Symptom Score (TNSS + TNNSS), Rhinitis-Related Quality of Life Questionnaire (RQLQ), Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), anterior rhinoscope (ENT), Pulmonary Function Tests, etc. The safety of acoustic vibration therapy device and oscillating positive expiratory pressure therapy device in the treatment of nasal congestion will be clarified, specifically including the incidence of adverse events such as no epistaxis, dyspnea, etc. Hypothesis: In the treatment of subjects with nasal congestion as the main symptom, whether they have simple allergic rhinitis or allergic rhinitis complicated with asthma, nasal congestion and related symptoms are significantly improved after daily treatment with acoustic vibration or oscillating positive expiratory pressure devices 3 times a day.
Interventions
DEVICEVPAT (Vibratory Positive Pressure Therapeutic Apparatus）
VPAT (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.
DRUGbasic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA
All 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.
DEVICEOPEP（Oscillating Positive Expiratory Pressure device）
Oscillating 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.
Sponsors
Huzhou Central Hospital
The Children's Hospital of Zhejiang University School of Medicine
First People's Hospital of Hangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
A Randomized, double-Blind, Multi-Center，Placebo-Controlled Parallel-Group Clinical Trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Nasal Inspiratory Flow (PNIF) | These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analogue Scale ) | These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use. | — |
| Total Nasal Symptom Score + Total Non-Nasal Symptom Score (TNSS + TNNSS) | These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use. | — |
| RQLQ(Rhinitis-Related Quality of Life Questionnaire ) | These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use. | — |
| FeNO (Fractional Exhaled Nitric Oxide) | These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use. | — |
| Peak Expiratory Flow (PEF) | These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use. | — |
| AQLQ(Asthma Quality of Life Questionnaire ) | These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use. | — |
| anterior rhinoscope | These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use.The anterior rhinoscope is used to examine for the presence of bleeding, aggravated ulcers. | The anterior rhinoscope is used to examine for the presence of bleeding, aggravated ulcers, and other conditions, so as to ensure that adverse reactions such as increased bleeding and severe hemorrhage (which may result from the potential aggravation of ulceration and erosion in areas like the nasal vestibule) do not occur during the treatment process. |
| Pulmonary Function Test FEV1/FVC ratio | up to 8 weeks | We will examine the patients' pulmonary function test data at the time of enrollment and after 8 weeks of treatment, respectively. Specifically, this will mainly include improvements in the statistical results of FEV1/FVC%Pred (predicted percentage of forced expiratory volume in 1 second to forced vital capacity ratio) |
| Pulmonary Function Test | up to 8 weeks | We will examine the patients' pulmonary function test FEV1%Pred (predicted percentage of forced expiratory volume in 1 second). |
| ACT(Asthma Control Test ) | These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use. | — |
Countries
China
Contacts
Primary ContactHuiying Wang, Doctor(PhD,MD)
Outcome results
None listed