Allergic RhinitisNCT05506709
Sterimar Allergic Rhinitis
A study testing Seawater nasal spray in people with Allergic Rhinitis, run by Church & Dwight Company, Inc. at 1 site in Armenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Seawater nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteArmenia
- Study dates
- 13 Jul 2022to 21 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Research Trial Confirming the Safety and Performance of a Seawater-based Nasal Spray for Relief of Allergic Rhinitis Symptoms
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.
- Conditions
- Allergic Rhinitis
- Being tested
- Seawater nasal spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seawater nasal sprayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Seawater nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Through study completion, an average of 3 weeks
Secondary outcomes (7)
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.
Measured: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) for itching
Ocular Symptom Score (OSS) will be assessed by questionnaire with scoring from 0 (none) to 3(severe).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start13 Jul 2022
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506709
- Sponsor's protocol ID
- ST-20-F12
- Status last verified
- Oct 2022
- First submitted
- 15 Aug 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research Trial Confirming the Safety and Performance of a Seawater-based Nasal Spray for Relief of Allergic Rhinitis Symptoms
- ClinicalTrials.gov ID
- NCT05506709
- Acronym / sponsor ID
- ST-20-F12
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: Seawater nasal spraySubjects 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seawater nasal spraySubjects 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. | Device | Test |
Primary outcome
Total Nasal Symptom Score (TNSS)
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).
Nasal Symptom Score (NSS) for (congestion (stuffy/blocked nose)
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).
Nasal Symptom Score (NSS) for sneezing
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).
Nasal Symptom Score (NSS) for itching
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).
Nasal Symptom Score (NSS) for runny nose
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).
7 secondary outcomes
Total Ocular Symptom Score (TOSS)
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) for itching
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) for watering
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) for puffy eyes
Time frame: Through study completion, an average of 3 weeks
Ocular Symptom Score (OSS) for dry/irritated/burning eyes
Time frame: Through study completion, an average of 3 weeks
Onset of relief (immediate relief)
Time frame: Through study completion, an average of 3 weeks
Duration of relief (long-lasting)
Time frame: Through study completion, an average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seawater nasal spray in people with Allergic Rhinitis, run by Church & Dwight Company, Inc. at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (TNSS) (time frame: Through study completion, an average of 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.