"Heratsi" Hospital Complex No.1
Yerevan, 0025, Armenia
NCT Number: NCT05506709
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Yerevan, 0025, Armenia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Through study completion, an average of 3 weeks
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.
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Time frame: Through study completion, an average of 3 weeks
Onset of relief will be using TNSS and individual NSS scores assessed at 1min, 10min and 1 hour after product application.
Time frame: Through study completion, an average of 3 weeks
Duration of relief using the time between first and second daily applications. Time of application will be recorded by subject daily.
Time frame: Through study completion, an average of 3 weeks
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
Time frame: Through study completion, an average of 3 weeks
subjects will be asked whether they need other medication to treat their symptoms.
Church & Dwight Company, Inc.
Industry
A Clinical Research Trial Confirming the Safety and Performance of a Seawater-based Nasal Spray for Relief of Allergic Rhinitis Symptoms
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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