Seasonal Allergic RhinitisEHANCT04752956
Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis
A study testing "Total nasal symptom score" (TNSS), Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ) and Nasal cytology in people with Seasonal Allergic Rhinitis, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
Nasal irrigation (NI) is recommended as an add-on therapy in patients with allergic rhinitis (AR). The primary purpose of this study was to evaluate the clinical effectiveness of adding hyaluronic acid (HA) solution and normal saline (NSS) to nasal steroid (NS) therapy as add - on therapy in improving quality of life… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- "Total nasal symptom score" (TNSS), Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ) and Nasal cytology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Mar 2019to 6 Jun 2021
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients between 6 to 12-year-old;
- Children must have a clinical history concordant to seasonal allergic rhinitis of the previous year;
- Children must have skin prick test (SPT) positivity to pollen (tree, grass, or weed) (Positive SPT is defined as; skin reaction with within 15 minutes after the test and 3 mm larger swelling compared to the negative control test; ALK, Hørsholm, Denmark)
- Children must have a total nasal symptom score (TNSS) of 4 or more on 4 of 7 days during the run-in period.
Who cannot join
- Children who were treated with systemic/topical nasal corticosteroids, antihistamines or antibiotics, leukotriene receptor antagonists 4 weeks before the examination,
- those who had upper or lower respiratory tract infections;
- recipients of recent or ongoing allergen immunotherapy;
- active smokers;
- those with cystic fibrosis, immunodeficiency, septal deviation, nasal polyps, and ostio-metal complex, exudation, abnormal nasal diagnostic function, nasal anatomical disorder, metabolic disease, or congenital disease.
- Phone calls will measure children's adherence rate to treatment protocols, and participants determined to have treatment protocol adherence rates below 85% will be excluded.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11
Ankara, Etlik, 06010
Gülhane Training and Research Hospital
Ankara, 06010
About this study
Nasal irrigation (NI) is recommended as an add-on therapy in patients with allergic rhinitis (AR). The primary purpose of this study was to evaluate the clinical effectiveness of adding hyaluronic acid (HA) solution and normal saline (NSS) to nasal steroid (NS) therapy as add - on therapy in improving quality of life and reducing nasal symptom scores of children with seasonal AR (SAR) with regards to NS therapy. Our secondary purpose was to demonstrate the effects on eosinophil count in nasal cytology (NEC), nasal airflow (NAF), and resistance (NAR).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- "Total nasal symptom score" (TNSS), Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ), Nasal cytology, anterior rhinomanometry
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Total nasal symptom score" (TNSS)Other
TNSS contains 4 parameters in assessing the severity of allergic rhinitis: nasal congestion, runny nose, nasal itching, and sneezing. Each symptom is scored out of 4 points, from 0 to 3. 0, none- there are no complaints 1- mild- any symptom that exists but is not particularly annoying; 2, moderate, - any annoying symptom but does not interfere with daily activities or sleep; 3, severe - any symptom preventing daily activities or disturbing during sleeping. The total score is calculated by summing all the scores of 4 fields, which vary ranges from 0 to 15 .In our study, all patients will be instructed to record their TNSS symptom scores on their diary cards each morning before taking the drug. Patients will be graded on baseline TNSS parameters compared to 4 weeks before starting treatment.
Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ)Behavioural
PRQLQ, is a self-administered, disease-specific questionnaire, evaluating physical, emotional, and social status of individuals with AR. It contains 23 items in 5 domains: nose symptoms (RS), eye symptoms (ES), practical problems (PF), activity limitation (RL) and other symptoms (OS). One score is given to each domain. 7-point scale (from 0, not problematic; to 6, very problematic). The overall score is derived from the average score of all items (20). In our study, the Turkish validated form of PRQLQ was used
Patients will be asked to answer PRQLQ questions at the end of each week during treatment. At the end of the treatment, an average of 4 weeks will be taken as the PRQLQ score. Basal PRQLQ questions will be evaluated by the participants based on 4 weeks prior to treatment.
Nasal cytologyDiagnostic test
In anterior rhinoscopy, nasal cytology will be scraped off the middle part of the lower turbinate with the help of a small sterile cotton swab. The cellular material obtained will be fixed by air drying on a glass slide and then stained by the May-Grünwald-Giemsa method. Preparations that do not contain respiratory epithelium or contain less than 10 epithelium at high magnification will be excluded from the study. A percentage of cells per 100 cells will be reported. NECs (nasal eosinophilic count) will be evaluated according to the quantitative classification of Gelardi et al. An experienced cytologist who is blind to the study groups will perform this test. Eosinophil percentages in nasal smears of all patients will be evaluated before and after the treatment.
anterior rhinomanometryDiagnostic test
Children's right, left and total nasal airway resistance (NAR) and nasal airflow (NAF) will be measured with active anterior rhinomanometry ZAN 100 USB Rhinomanometry (Longmont, Colo., USA). In the evaluation, the NAR- pressure difference / air flow (R = P / V) formula will be used at a constant 150 Pascal prescribed by the European Rinomanometry Standardization Committee in 1984. After the patient is rested for 20 minutes, measurements will be made at 20-22 ° C and the nasal secretion will be cleared. NAR and NAF values of the participants will be measured before starting treatment and 4 weeks after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Grup1 | Active comparator | Nasal steroid spray only (NS) (Each dose contains 27.5 micrograms of fluticasone furoate; administered single dose per day as 1 puff through both nostrils) Receives: Other: "Total nasal symptom score" (TNSS); Behavioral: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ); Diagnostic Test: Nasal cytology; Diagnostic Test: anterior rhinomanometry |
| Grup 2 | Active comparator | NS + administered ambient temperature normal saline (NSS) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (NSS; 0,09% NaCl, pH:4-5) Receives: Other: "Total nasal symptom score" (TNSS); Behavioral: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ); Diagnostic Test: Nasal cytology; Diagnostic Test: anterior rhinomanometry |
| Grup 3 | Active comparator | NS + administered ambient temperature hyaluronic acid (HA) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (Nasorinse plus pediatric® Ingredients: water, sodium chlorine, sodium bicarbonate, and HA; pH balanced) Receives: Other: "Total nasal symptom score" (TNSS); Behavioral: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ); Diagnostic Test: Nasal cytology; Diagnostic Test: anterior rhinomanometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of "total nasal symptom score" surveys
The primary outcome will be to understand whether nasal irrigation with hyaluronic acid (HA) solution will be beneficial as add-on therapy in children who are already receiving nasal steroid (NS) therapy.
Total Nasal Symptom Scores (TNSS) of all participants (the study and control groups) will be used in grading the symptom relief of seasonal allergic rhinitis.
Each symptom (nasal congestion, runny nose, nasal itching, and sneezing) will be graded from 0-3 (0=None, 1=Mild, 2=Moderate, 3=Severe) by the participants during the screening. No special unit for the scoring system is identified according to TNSS (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome).
Measured: 28 days
Results of "Pediatric rhinoconjunctivitis quality of life questionnaire" survey
PRQLQ is a self-administered, disease-specific questionnaire and the survey contains 23 items in 5 domains: nose symptoms (RS), eye symptoms (ES), practical problems (PF), activity limitation (RL) and other symptoms (OS). One score is given to each domain. 7-point scale (from 0, not problematic; to 6, very problematic). The overall score will be derived from the average score of all items.
No special unit for the scoring system is identified according to PRQLQ (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome 2).
Measured: 28 days
Secondary outcomes (3)
Nasal smear eosinophil count (percentages)
- Nasal cytology in anterior rhinoscopy, the middle part of the lower concave will be scraped with the help of a small sterile cotton swab. Slides will be first screened under microscopes to determine the adequacy and cellular areas of the sample at 100 magnification. Slides will be dripped immersion oil and screened under an optic microscope x 1.000 magnification equipped with a digital camera. Analysis of rhino cystograms will involve screening at least 50 fields (300 cells). A percentage of the cell per 100 cells will be reported. NECs (nasal eosinophilic count) will be evaluated according to quantitative classification system described previously by Gelardi et al. Grade 0: No cell; Grade ½: 0,1-1% Eosinophil; Grade 1: 1.1-5% Eosinophil; Grade 2: 5-15% Eosinophil; Grade 3: 15-20% Eosinophil; Grade 4: > 20% Eosinophil. Eosinophil percentages in nasal smears of all patients will be evaluated before and at the end of treatment.
Measured: Two days
Nasal airflow (NAF) (ccm/sn)
Nasal airflow (NAF) will be measured by means of active anterior rhinomanometry ZAN 100 USB Rhinomanometry (Longmont, Colo., USA) device. Measurements will be conducted at 20-22 °C after the patient rests for 20 minutes and the nasal secretion will be cleaned. NAF values of the participants will be measured before initiating the treatment and after 4 weeks of the treatment.
Measured: Two days
Nasal resistance (NAR) (Pa. s/ml)
Nasal resistance (NAR) will be measured with active anterior rhinomanometry ZAN 100 USB Rhinomanometry device (Longmont, Colo., USA). In the evaluation, the formula NAR- pressure difference/airflow (R = P/V) will be used in the constant 150 Pascal stipulated by the European Rhinomanometry Standardization Committee in 1984.
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start3 Mar 2019
- Primary completion6 Jun 2020
- Study completion6 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı ERCAN, Saglik Bilimleri Universitesi
- Investigators
- Nazli Ercan, MD, Study director, University of Health Sciences, Gulhane Research and Training Hospital, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752956
- Sponsor's protocol ID
- HA2021
- Acronym
- EHA
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savietto E, Marioni G, Maculan P, Pettorelli A, Scarpa B, Simoni E, Astolfi L, Marchese-Ragona R, Ottaviano G. Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study. Am J Otolaryngol. 2020 Jul-Aug;41(4):102502. doi: 10.1016/j.amjoto.2020.102502. Epub 2020 May 7.
PubMed 32460989Ercan N, Demirel F, Yesillik S, Bolat A, Kartal O. Efficacy of sodium hyaluronate in relieving nasal symptoms of children with intermittent allergic rhinitis: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2022 Jun;279(6):2925-2934. doi: 10.1007/s00405-021-07073-0. Epub 2021 Sep 16.
PubMed 34529156
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT04752956
- Acronym / sponsor ID
- EHA / HA2021
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 6 Jun 2021 (estimated)
- First posted
- 12 Feb 2021 (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.
Nasal irrigation (NI) is recommended as an add-on therapy in patients with allergic rhinitis (AR). The primary purpose of this study was to evaluate the clinical effectiveness of adding hyaluronic acid (HA) solution and normal saline (NSS) to nasal steroid (NS) therapy as add - on therapy in improving quality of life and reducing nasal symptom scores of children with seasonal AR (SAR) with regards to NS therapy. Our secondary purpose was to demonstrate the effects on eosinophil count in nasal cytology (NEC), nasal airflow (NAF), and resistance (NAR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grup1 | Active comparator | Other: "Total nasal symptom score" (TNSS), Behavioral: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ), Diagnostic Test: Nasal cytology, Diagnostic Test: anterior rhinomanometryNasal steroid spray only (NS) (Each dose contains 27.5 micrograms of fluticasone furoate; administered single dose per day as 1 puff through both nostrils) |
| Grup 2 | Active comparator | Other: "Total nasal symptom score" (TNSS), Behavioral: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ), Diagnostic Test: Nasal cytology, Diagnostic Test: anterior rhinomanometryNS + administered ambient temperature normal saline (NSS) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (NSS; 0,09% NaCl, pH:4-5) |
| Grup 3 | Active comparator | Other: "Total nasal symptom score" (TNSS), Behavioral: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ), Diagnostic Test: Nasal cytology, Diagnostic Test: anterior rhinomanometryNS + administered ambient temperature hyaluronic acid (HA) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (Nasorinse plus pediatric® Ingredients: water, sodium chlorine, sodium bicarbonate, and HA; pH balanced) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients between 6 to 12-year-old;
- Children must have a clinical history concordant to seasonal allergic rhinitis of the previous year;
- Children must have skin prick test (SPT) positivity to pollen (tree, grass, or weed) (Positive SPT is defined as; skin reaction with within 15 minutes after the test and 3 mm larger swelling compared to the negative control test; ALK, Hørsholm, Denmark)
- Children must have a total nasal symptom score (TNSS) of 4 or more on 4 of 7 days during the run-in period.
Key exclusion criteria (6 listed)
- Children who were treated with systemic/topical nasal corticosteroids, antihistamines or antibiotics, leukotriene receptor antagonists 4 weeks before the examination,
- those who had upper or lower respiratory tract infections;
- recipients of recent or ongoing allergen immunotherapy;
- active smokers;
- those with cystic fibrosis, immunodeficiency, septal deviation, nasal polyps, and ostio-metal complex, exudation, abnormal nasal diagnostic function, nasal anatomical disorder, metabolic disease, or congenital disease.
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 |
|---|---|---|
| "Total nasal symptom score" (TNSS)TNSS contains 4 parameters in assessing the severity of allergic rhinitis: nasal congestion, runny nose, nasal itching, and sneezing. Each symptom is scored out of 4 points, from 0 to 3. 0, none- there are no complaints 1- mild- any symptom that exists but is not particularly annoying; 2, moderate, - any annoying symptom but does not interfere with daily activities or sleep; 3, severe - any symptom preventing daily activities or disturbing during sleeping. The total score is calculated by summing all the scores of 4 fields, which vary ranges from 0 to 15 .In our study, all patients will be instructed to record their TNSS symptom scores on their diary cards each morning before taking the drug. Patients will be graded on baseline TNSS parameters compared to 4 weeks before starting treatment. | Other | Grup 2, Grup 3, Grup1 |
| Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ)PRQLQ, is a self-administered, disease-specific questionnaire, evaluating physical, emotional, and social status of individuals with AR. It contains 23 items in 5 domains: nose symptoms (RS), eye symptoms (ES), practical problems (PF), activity limitation (RL) and other symptoms (OS). One score is given to each domain. 7-point scale (from 0, not problematic; to 6, very problematic). The overall score is derived from the average score of all items (20). In our study, the Turkish validated form of PRQLQ was used Patients will be asked to answer PRQLQ questions at the end of each week during treatment. At the end of the treatment, an average of 4 weeks will be taken as the PRQLQ score. Basal PRQLQ questions will be evaluated by the participants based on 4 weeks prior to treatment. | Behavioural | Grup 2, Grup 3, Grup1 |
| Nasal cytologyIn anterior rhinoscopy, nasal cytology will be scraped off the middle part of the lower turbinate with the help of a small sterile cotton swab. The cellular material obtained will be fixed by air drying on a glass slide and then stained by the May-Grünwald-Giemsa method. Preparations that do not contain respiratory epithelium or contain less than 10 epithelium at high magnification will be excluded from the study. A percentage of cells per 100 cells will be reported. NECs (nasal eosinophilic count) will be evaluated according to the quantitative classification of Gelardi et al. An experienced cytologist who is blind to the study groups will perform this test. Eosinophil percentages in nasal smears of all patients will be evaluated before and after the treatment. | Diagnostic test | Grup 2, Grup 3, Grup1 |
| anterior rhinomanometryChildren's right, left and total nasal airway resistance (NAR) and nasal airflow (NAF) will be measured with active anterior rhinomanometry ZAN 100 USB Rhinomanometry (Longmont, Colo., USA). In the evaluation, the NAR- pressure difference / air flow (R = P / V) formula will be used at a constant 150 Pascal prescribed by the European Rinomanometry Standardization Committee in 1984. After the patient is rested for 20 minutes, measurements will be made at 20-22 ° C and the nasal secretion will be cleared. NAR and NAF values of the participants will be measured before starting treatment and 4 weeks after treatment. | Diagnostic test | Grup 2, Grup 3, Grup1 |
Primary outcome
Results of "total nasal symptom score" surveys
Time frame: 28 days
The primary outcome will be to understand whether nasal irrigation with hyaluronic acid (HA) solution will be beneficial as add-on therapy in children who are already receiving nasal steroid (NS) therapy. Total Nasal Symptom Scores (TNSS) of all participants (the study and control groups) will be used in grading the symptom relief of seasonal allergic rhinitis. Each symptom (nasal congestion, runny nose, nasal itching, and sneezing) will be graded from 0-3 (0=None, 1=Mild, 2=Moderate, 3=Severe) by the participants during the screening. No special unit for the scoring system is identified according to TNSS (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome).
Results of "Pediatric rhinoconjunctivitis quality of life questionnaire" survey
Time frame: 28 days
PRQLQ is a self-administered, disease-specific questionnaire and the survey contains 23 items in 5 domains: nose symptoms (RS), eye symptoms (ES), practical problems (PF), activity limitation (RL) and other symptoms (OS). One score is given to each domain. 7-point scale (from 0, not problematic; to 6, very problematic). The overall score will be derived from the average score of all items. No special unit for the scoring system is identified according to PRQLQ (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome 2).
3 secondary outcomes
Nasal smear eosinophil count (percentages)
Time frame: Two days
Nasal airflow (NAF) (ccm/sn)
Time frame: Two days
Nasal resistance (NAR) (Pa. s/ml)
Time frame: Two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Results publication: PubMed 32460989Savietto E, Marioni G, Maculan P, Pettorelli A, Scarpa B, Simoni E, Astolfi L, Marchese-Ragona R, Ottaviano G. Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study. Am J Otolaryngol. 2020 Jul-Aug;41(4):102502. doi: 10.1016/j.amjoto.2020.102502. Epub 2020 May 7.
- Derived from this study: PubMed 34529156Ercan N, Demirel F, Yesillik S, Bolat A, Kartal O. Efficacy of sodium hyaluronate in relieving nasal symptoms of children with intermittent allergic rhinitis: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2022 Jun;279(6):2925-2934. doi: 10.1007/s00405-021-07073-0. Epub 2021 Sep 16.
- Individual participant dataSharing planned: No
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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.
Nazli Ercan, MD study director
University of Health Sciences, Gulhane Research and Training Hospital, Department of Pediatrics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Total nasal symptom score" (TNSS), Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ) and Nasal cytology in people with Seasonal Allergic Rhinitis, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Results of "total nasal symptom score" surveys (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752956, which also lists 2 linked publications.
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 12 Feb 2021.