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Sterimar Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Not Applicable

Locations

Armenia

Study Type

Interventional

Intervention

Seawater nasal spray

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

"Heratsi" Hospital Complex No.1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test

Arm Description

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)

Outcomes

Primary Outcome Measures

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).

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).

Nasal Symptom Score (NSS) for sneezing

Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).

Nasal Symptom Score (NSS) for itching

Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).

Nasal Symptom Score (NSS) for runny nose

Nasal Symptom Score (NSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).

Secondary Outcome Measures

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.

Ocular Symptom Score (OSS) for itching

Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).

Ocular Symptom Score (OSS) for watering

Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).

Ocular Symptom Score (OSS) for puffy eyes

Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).

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).

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.

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.

Full Information

NCT ID

NCT05506709

First Posted

August 15, 2022

Last Updated

October 17, 2022

Sponsor

Church & Dwight Company, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05506709

Brief Title

Sterimar Allergic Rhinitis

Official Title

A Clinical Research Trial Confirming the Safety and Performance of a Seawater-based Nasal Spray for Relief of Allergic Rhinitis Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

July 13, 2022 (Actual)

Primary Completion Date

September 21, 2022 (Actual)

Study Completion Date

September 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Church & Dwight Company, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Product-blinded (the brand name of the product is not available for subjects)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Seawater nasal spray

Intervention Description

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.

Primary Outcome Measure Information:

Title

Total Nasal Symptom Score (TNSS)

Description

Time Frame

Through study completion, an average of 3 weeks

Title

Nasal Symptom Score (NSS) for (congestion (stuffy/blocked nose)

Description

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

Title

Nasal Symptom Score (NSS) for sneezing

Description

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

Title

Nasal Symptom Score (NSS) for itching

Description

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

Title

Nasal Symptom Score (NSS) for runny nose

Description

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

Secondary Outcome Measure Information:

Title

Total Ocular Symptom Score (TOSS)

Description

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

Title

Ocular Symptom Score (OSS) for itching

Description

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

Title

Ocular Symptom Score (OSS) for watering

Description

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

Title

Ocular Symptom Score (OSS) for puffy eyes

Description

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

Title

Ocular Symptom Score (OSS) for dry/irritated/burning eyes

Description

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

Title

Onset of relief (immediate relief)

Description

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

Title

Duration of relief (long-lasting)

Description

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

Other Pre-specified Outcome Measures:

Title

Weekly Rhinitis Control

Description

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

Title

Need of other medications

Description

subjects will be asked whether they need other medication to treat their symptoms.

Time Frame

Through study completion, an average of 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Facility Information:

Facility Name

"Heratsi" Hospital Complex No.1

City

Yerevan

ZIP/Postal Code

0025

Country

Armenia

12. IPD Sharing Statement

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Sterimar Allergic Rhinitis

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