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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Subjects receive only the test product (medical device/nasal pump containing moderately hypertonic solution produced based on 100% natural sea water rich of marine trace elements with added manganese and calcium) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seawater nasal spray | Device | Subjects will use the nasal spray (moderately hypertonic solution based on 100% natural sea water rich of marine trace elements with added manganese and calcium) at least once and up to 6 times as necessary per day during the 14-day test period. Each application is composed of two irrigating sprays per nostril for a total of 4 sprays per application. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | 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). | Through study completion, an average of 3 weeks |
| Nasal Symptom Score (NSS) for (congestion (stuffy/blocked nose) | Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). | Through study completion, an average of 3 weeks |
| Nasal Symptom Score (NSS) for sneezing | Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). | Through study completion, an average of 3 weeks |
| Nasal Symptom Score (NSS) for itching | Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). | Through study completion, an average of 3 weeks |
| Nasal Symptom Score (NSS) for runny nose | Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). | Through study completion, an average of 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Ocular Symptom Score (TOSS) | The Total Ocular Symptom Score (TOSS) comprised of the sum of the 4 individual ocular symptoms scores: itching, watering, puffy eyes, dry/irritated/burning eyes. | Through study completion, an average of 3 weeks |
| Ocular Symptom Score (OSS) for itching |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Rhinitis Control | Subjects will complete Weekly rhinitis control questionnaire for the past week. They grade their symptoms during the week from 5 to 1, where higher score means better outcome | Through study completion, an average of 3 weeks |
| Need of other medications |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Heratsi" Hospital Complex No.1 | Yerevan | 0025 | Armenia |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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Product-blinded (the brand name of the product is not available for subjects)
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|
Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). |
| Through study completion, an average of 3 weeks |
| Ocular Symptom Score (OSS) for watering | Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). | Through study completion, an average of 3 weeks |
| Ocular Symptom Score (OSS) for puffy eyes | Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). | Through study completion, an average of 3 weeks |
| Ocular Symptom Score (OSS) for dry/irritated/burning eyes | Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe). | Through study completion, an average of 3 weeks |
| Onset of relief (immediate relief) | Onset of relief will be using TNSS and individual NSS scores assessed at 1min, 10min and 1 hour after product application. | Through study completion, an average of 3 weeks |
| Duration of relief (long-lasting) | Duration of relief using the time between first and second daily applications. Time of application will be recorded by subject daily. | Through study completion, an average of 3 weeks |
subjects will be asked whether they need other medication to treat their symptoms. |
| Through study completion, an average of 3 weeks |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |