A Clinical Research Trial Confirming the Safety and Performance of a Seawater-based Nasal Spray for Relief of Allergic Rhinitis Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Total Nasal Symptom Score (TNSS)
研究概览
简要总结
The study aims to confirm the safety and performance of a hypertonic seawater-based nasal spray enriched with manganese and calcium, in relief/reduction of nasal symptoms (congestion, itchy nose, runny nose and sneezing) among subjects with symptomatic allergic rhinitis. This will be a prospective, longitudinal, single-cell and product blinded clinical trial. A sufficient number (65-70) of adult subjects with allergic rhinitis meeting all eligibility criteria will be enrolled in this study to ensure that approximately 50 subjects complete the study. Subjects will be enrolled during allergy season. The study will consist of four visits with a total duration of 3 weeks (1 week of pre-screening and 2 weeks for investigational product use). The full schedule of events is presented in the CIP. Subjects recruited for this study will be screened for inclusion/exclusion criteria after reading and signing the informed consent form. Eligible subjects who show a positive reaction to the skin prick test at Visit 1/ Day -7 will be enrolled for a one-week pre-run screening period. At baseline (Visit 2/Day 0), those subjects meeting all inclusion criteria including the results of the Total Nasal Symptoms Score will be enrolled in the active study phase. The subjects will use the product during two weeks (from Day 7 to Day 14), applying at least once and maximum 6 times daily per instructions for use.
At each visit within intervention period (Visits 2, 3 and 4), the subjects will be asked to assess their nasal and ocular symptoms (using Nasal Symptom Score and Ocular Symptom Score grading tools) before product application, as well as at 1 minute, 10 minutes and 1-hour post-product application. Besides, they will complete Weekly Rhinitis questionnaire for the past week. Additionally, the subjects will complete Daily Diaries to record their nasal and ocular symptoms, sleep disturbance, and need for use of other medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Product-blinded (the brand name of the product is not available for subjects)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years of age.
- •Male or female.
- •Self-reported or medical history of allergic rhinitis during the past 18 months.
- •Having a positive skin puncture test (wheal diameter at least 3 mm greater than saline negative control) to at least one pollen of trees, weeds, and grasses meadows. Specific strains will be noted in the skin prick test report [Note: Subjects should also receive skin prick/puncture tests for perennial allergens, and they can be polysensitized to perennial allergens (dust mites, house dust, dog dander, cat dander, feather)].
- •Willingness NOT to use any medications for relief of allergic rhinitis symptoms during the 3 weeks of the study.
- •Being able to read and sign informed consent, as well as fill assessment questionnaire.
- •Daily TNSS ≥6 of possible maximum 12 on at least 3 consecutive days, or daily TNSS ≥5 of possible maximum of 12 with one symptom being severe on at least 3 consecutive days of the 1-week run-in period before the baseline visit (Visit 2/Day 0) (based on the nasal symptoms listed in Appendix I). Daily TNSS is the average of morning (within 15 minutes of awakening) and evening TNSS (within an hour before going to bed) to be calculated by the study staff at baseline (Visit 2/Day 0)
排除标准
- •Any symptoms of upper or lower respiratory tract infections within 2 weeks prior to the first visit or during the study.
- •Positive COVID -19 test during the past month or during the course of the study.
- •Self-reported history of anaphylaxis.
- •Confirmed diagnosis of urticaria or eczema.
- •Confirmed diagnosis of asthma that requires more than intermittent rescue beta agonist treatment, for example, prior to exercise.
- •Immunotherapy during the past 2 years, or ongoing immunotherapy.
- •Recent nasal or sinus surgery within the last 6 months.
- •Use of any OTC and prescription antihistamine, cromone, decongestant, systemic/topical corticosteroids, leukotriene antagonists, topical antibiotics, non-steroidal anti-inflammatory drugs in the past 2 weeks.
- •Use of other nasal sprays, pump, CPAP machine, nasal irrigation/lavage devices, internal nasal gel or nasal oil within 2 weeks prior to the first visit or during the study.
- •Women who are pregnant and/or breastfeeding or planning to become pregnant during the study and within 30 days after the last application of the study product.
- •Presence of nasal polyposis, chronic sinusitis (assessed by Investigator).
- •Nasal anatomic abnormality (assessed by Investigator), e.g., severe deviated septum, congenital cleft lip/palate, nasal bleeding diathesis.
- •Any clinically significant co-morbid condition, which, in PI's opinion, may affect the patient safety and/or affect participation in the study
结局指标
主要结局
Total Nasal Symptom Score (TNSS)
时间窗: Through study completion, an average of 3 weeks
The Total Nasal Symptom Score (TNSS) is the sum of the 4 individual nasal symptoms scores: nasal itching, congestion, runny nose, sneezing. Symptoms will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Nasal Symptom Score (NSS) for sneezing
时间窗: Through study completion, an average of 3 weeks
Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Nasal Symptom Score (NSS) for runny nose
时间窗: Through study completion, an average of 3 weeks
Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Nasal Symptom Score (NSS) for (congestion (stuffy/blocked nose)
时间窗: Through study completion, an average of 3 weeks
Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Nasal Symptom Score (NSS) for itching
时间窗: Through study completion, an average of 3 weeks
Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
次要结局
- Total Ocular Symptom Score (TOSS)(Through study completion, an average of 3 weeks)
- Ocular Symptom Score (OSS) for itching(Through study completion, an average of 3 weeks)
- Ocular Symptom Score (OSS) for puffy eyes(Through study completion, an average of 3 weeks)
- Onset of relief (immediate relief)(Through study completion, an average of 3 weeks)
- Duration of relief (long-lasting)(Through study completion, an average of 3 weeks)
- Ocular Symptom Score (OSS) for dry/irritated/burning eyes(Through study completion, an average of 3 weeks)
- Ocular Symptom Score (OSS) for watering(Through study completion, an average of 3 weeks)