Allergic RhinitisNCT04532762
Demonstration of a Decongestant Effect of "Coldamaris Akut" Compared to Saline Nasal Spray.
A study testing nasal spray in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by Marinomed Biotech AG at 1 site in Austria.
Trial summary
Allergic rhinitis (AR) in its seasonal and perennial form is a common allergic condition. The majority of allergic rhinitis sufferers report nasal (congestion, sneezing, itching and rhinorrhea) and ocular (redness, watery eyes, itching and burning) symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 4 Aug 2020to 31 Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained before any trial related procedures are performed
- Healthy male or female subjects aged 18 to 65 years
- A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years
- Subjects exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total nasal symptom score (TNSS) of at least 6 (out of 12) with the necessity to score at least "moderate = 2" for the single symptom "nasal congestion" using standard VCC grass pollen allergen mixture. Nasal symptom score is the sum of "nasal congestion", "rhinorrhea", "itchy nose" and "sneezing", each of which have been scored on a categorical scale from 0 to 3.
- Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 12 months prior to study start.
- Positive serum specific IgE against recombinant major allergen components of the used grass pollen e.g. g6 (specific CAP IgE ≥0.70 kU/L) at screening or within the last 12 months prior to study start.
Show all 11Show fewer
- Asthma patients only if the asthma condition is mild or intermittent, and if those are not treated with steroids
- Subject has a forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value (ECCS) at the screening.
- Subject is capable of understanding the study procedures and potential risks associated with the study, and voluntarily agrees to participate by giving written informed consent.
- Subject is able to adhere to dose and visit schedules.
- Subject is able to read, understand and complete questionnaires and diaries.
Who cannot join
- A clinical history of uncontrolled asthma within 3 months prior to screening
- Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the
- investigator
- Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years
- Ongoing treatment with any allergen-specific immunotherapy product
- Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other
Show all 25Show fewer
- relevant infectious process at randomisation
- Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of
- nasal turbinates judged by the investigator
- Subjects using any ophthalmic steroids during the last 30 days
- Subjects treated with nasal, inhaled or systemic steroids during the last 30 days
- History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs
- or an idiopathic reaction)
- Any clinically relevant chronic disease judged by the investigator
- Systemic disease affecting the immune system judged by the investigator
- Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
- History of allergy, hypersensitivity or intolerance to any ingredients of the study medication
- History of alcohol or drug abuse.
- Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child,grandparent or grandchild
- Subjects treated with leukotriene antagonists (1 month before study start), long-lasting anti-histamines, like
- cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (5 to 10 days before study start), mast cell
- stabilizer (2 weeks before study start) or nasal decongestant (3 days before study start)
- Subjects with an acute or chronic sinusitis judged by the investigator
- Positive Serology result judged by the investigator
- Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted and safe birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demonstration of a Decongestant Effect of "Coldamaris Akut" Compared to Saline Nasal Spray in Subjects Suffering From Grass Pollen Induced Rhinitis/Rhinoconjunctivitis.
Allergic rhinitis (AR) in its seasonal and perennial form is a common allergic condition. The majority of allergic rhinitis sufferers report nasal (congestion, sneezing, itching and rhinorrhea) and ocular (redness, watery eyes, itching and burning) symptoms.
Coldamaris akut nasal spray is a Carragelose® containing hyperosmolar solution that is indicated for supportive treatment in case of blocked nose due to rhinitis of any kind. Carragelose® is a sulfated polymer from red seaweed also widely used in the food industry and has GRAS status (FDA). The increased osmolality is based on the addition of sorbitol. This clinical study has the aim to show that Coldamaris akut has a mild decongestant effect.
Read more
This will be a prospective, controlled, double-blinded randomized two-way cross-over single site study in adult subjects (18 to 65 years) who demonstrate a grass pollen specific Immunoglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting two treatments, namely Coldamaris Akut and Coldamaris sine will be evaluated.
The objective of the trial is to demonstrate a decongestant effect on the nasal mucosa of patients treated with Coldamaris akut nasal spray compared to subjects treated with Coldamaris sine nasal spray in grass pollen induced rhinitis/rhinoconjunctivitis.
The evaluation will be based on the assessment of nasal congestion symptom during grass pollen challenge performed in the Vienna Challenge Chamber (environmental exposure chamber).
Secondary objective of the trial is to demonstrate the clinical performance of Coldamaris akut nasal spray on nasal symptoms compared to subjects treated with saline nasal spray.
Read the detailed description
This is a prospective, placebo-controlled, double-blinded randomized two-way cross-over single site study in adult subjects (18 to 65 years) who demonstrate a grass pollen specific Immunoglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting Coldamaris akut nasal spray will be evaluated compared to Coldamaris sine nasal spray.
Visit 1 - Screening:
At least one week prior to first treatment block, subjects will be screened for appropriate allergic response. A total nasal symptom score (TNSS) of at least 6 points out of 12 with a single symptom score for "nasal congestion" ≥ 2 within the first two hours in the grass pollen challenge chamber is required to be included into the study. If a screening for appropriate allergic response was done during the last 6 months, results from this allergy challenge can be used to fulfil the respective inclusion criteria.
Visit 2 - Inclusion:
In addition to the screening provocation the medical and allergic history, safety lab as well as retrieving inclusion and exclusion criteria will be assessed via anamnesis. Furthermore, all safety assessments will be conducted.
Note: Visit 1 and visit 2 could be done on the same day!
Visit 3: Day1 of first treatment period Eligible subjects will be randomly assigned to one of the two treatment arms (fully blinded) in the order of appearance and their screening numbers assigned at visit 1. Subjects will enter the study site about one hour ahead of the start of allergen provocation. After positive completion of all study relevant assessments, subjects will be randomized and enter the allergy challenge chamber for 6 hours. About one hour forty-five minutes after entry (after the eighth subjective score), the first treatment with the respective nasal spray will take place under staff supervision.
The subjective nasal symptom score will be recorded every fifteen minutes during a 6-hour allergen exposure challenge. Anterior rhinomanometry will be performed regularily.
Visit 4: Day1 of second treatment period Subjects will enter the study site about one hour ahead of the start of allergen provocation. In the following Visit 4 will be done in the same way as Visit 3.
Between the respective study treatments, a wash-out period of at least 7 days must be adhered to allowing complete symptom relief from previous challenge. After the wash-out period, subjects change to the second treatment block.
During the entire trial, subjects will be asked to monitor for adverse events (AEs), and they will record the use of concomitant medications on the provided form.
One week after the final provocation session, subjects will complete the trial after their follow up visit.
The trial design is appropriate for the indication studied. Validated methods of data collection, analysis, and evaluation will be used for the trial.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- nasal spray
- Keywords
- Allergic Rhinoconjunctivitis, Allergic Rhinitis, Coldamaris akut, Vienna Challenge Chamber, Nasal Congestion Symptom, Carrageenan, Carragelose, Iota-carrageenan
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal sprayDevice
Application of a nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Coldamaris akut | Experimental | One puff (140µl) into each nostril Receives: Device: nasal spray |
| Placebo | Placebo comparator | One puff (140µl) into each nostril Receives: Device: nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Congestion Symptom Score (NCSS)
calculated as the baseline adjusted mean of NCSS measured every 15 minutes during the grass pollen allergen exposure challenge from time-point 0 to 6 hours.
The NCSS is scored on a 4-point scale from 0-3 with "0"= none "1"=mild "2"=moderate "3"=severe
Measured: 0-6 hourse of allergen exposure challenge
Secondary outcomes (5)
Nasal airflow
will be assessed every 30 minutes during the six hour grass pollen allergen exposure challenge; an additional assessment takes place at timepoint 2:15
Measured: 0-6 hourse of allergen exposure challenge
Total nasal symptom score (TNSS)
Total nasal symptom score (TNSS) is the sum of the symptoms "nasal congestion", "rhinorrhea", "itchy nose","sneezing".
Each individual symptom of TNSS will be scored on a 4-point categorical scale from 0-3 (where "0"= none "1"=mild "2"=moderate "3"=severe).
Measured: 0-6 hourse of allergen exposure challenge
Total ocular symptom score (TOSS)
Total ocular symptom score (TOSS) is the sum of the symptoms "ocular itching", "redness", "watery eyes".
Each individual symptom of TOSS will be scored on a 4-point categorical scale from 0-3 (where "0"= none "1"=mild "2"=moderate "3"=severe). TOSS will be assessed every 15 minutes during the three hour grass pollen allergen exposure challenge.
Measured: 0-3 hourse of allergen exposure challenge
Total asthma symptom score (TASS)
Total asthma symptom score (TASS) is the sum of the symptoms "cough", "wheeze", "dyspnea".
Each individual symptom of TASS will be scored on a 4-point categorical scale from 0-3 (where "0"= none "1"=mild "2"=moderate "3"=severe). TASS will be assessed every 15 minutes during the three hour grass pollen allergen exposure challenge.
Measured: 0-3 hourse of allergen exposure challenge
Nasal secretion
will be assessed every 30 minutes during the six hour grass pollen allergen exposure challenge.
Measured: 0-6 hourse of allergen exposure challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start4 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, placebo-controlled, double-blinded randomized two-way cross-over single site study in adult subjects (18 to 65 years) who demonstrate a grass pollen specific Immunoglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting Coldamaris akut nasal spray will be evaluated compared to Coldamaris sine 0.5% nasal spray.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marinomed Biotech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva Prieschl-Grassauer, PhD, Study chair, CSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532762
- Sponsor's protocol ID
- COA_19_03
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Unger-Manhart N, Morokutti-Kurz M, Zieglmayer P, Russo A, Siegl C, Konig-Schuster M, Koller C, Graf P, Graf C, Lemell P, Savli M, Zieglmayer R, Dellago H, Prieschl-Grassauer E. Decongestant Effect of "Coldamaris Akut", a Carrageenan- and Sorbitol-Containing Nasal Spray in Seasonal Allergic Rhinitis. Int J Gen Med. 2024 Nov 8;17:5105-5121. doi: 10.2147/IJGM.S476707. eCollection 2024.
PubMed 39534593
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of a Decongestant Effect of "Coldamaris Akut" Compared to Saline Nasal Spray in Subjects Suffering From Grass Pollen Induced Rhinitis/Rhinoconjunctivitis.
- ClinicalTrials.gov ID
- NCT04532762
- Acronym / sponsor ID
- COA_19_03
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- Allergic Rhinoconjunctivitis, Allergic Rhinitis, Coldamaris akut, Vienna Challenge Chamber, Nasal Congestion Symptom, Carrageenan, Carragelose, Iota-carrageenan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Marinomed Biotech AGIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 Aug 2020 (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.
Allergic rhinitis (AR) in its seasonal and perennial form is a common allergic condition. The majority of allergic rhinitis sufferers report nasal (congestion, sneezing, itching and rhinorrhea) and ocular (redness, watery eyes, itching and burning) symptoms.
Coldamaris akut nasal spray is a Carragelose® containing hyperosmolar solution that is indicated for supportive treatment in case of blocked nose due to rhinitis of any kind. Carragelose® is a sulfated polymer from red seaweed also widely used in the food industry and has GRAS status (FDA). The increased osmolality is based on the addition of sorbitol. This clinical study has the aim to show that Coldamaris akut has a mild decongestant effect.
This will be a prospective, controlled, double-blinded randomized two-way cross-over single site study in adult subjects (18 to 65 years) who demonstrate a grass pollen specific Immunoglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting two treatments, namely Coldamaris Akut and Coldamaris sine will be evaluated.
The objective of the trial is to demonstrate a decongestant effect on the nasal mucosa of patients treated with Coldamaris akut nasal spray compared to subjects treated with Coldamaris sine nasal spray in grass pollen induced rhinitis/rhinoconjunctivitis.
The evaluation will be based on the assessment of nasal congestion symptom during grass pollen challenge performed in the Vienna Challenge Chamber (environmental exposure chamber).
Secondary objective of the trial is to demonstrate the clinical performance of Coldamaris akut nasal spray on nasal symptoms compared to subjects treated with saline nasal spray.
Detailed description
This is a prospective, placebo-controlled, double-blinded randomized two-way cross-over single site study in adult subjects (18 to 65 years) who demonstrate a grass pollen specific Immunoglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting Coldamaris akut nasal spray will be evaluated compared to Coldamaris sine nasal spray.
Visit 1 - Screening:
At least one week prior to first treatment block, subjects will be screened for appropriate allergic response. A total nasal symptom score (TNSS) of at least 6 points out of 12 with a single symptom score for "nasal congestion" ≥ 2 within the first two hours in the grass pollen challenge chamber is required to be included into the study. If a screening for appropriate allergic response was done during the last 6 months, results from this allergy challenge can be used to fulfil the respective inclusion criteria.
Visit 2 - Inclusion:
In addition to the screening provocation the medical and allergic history, safety lab as well as retrieving inclusion and exclusion criteria will be assessed via anamnesis. Furthermore, all safety assessments will be conducted.
Note: Visit 1 and visit 2 could be done on the same day!
Visit 3: Day1 of first treatment period Eligible subjects will be randomly assigned to one of the two treatment arms (fully blinded) in the order of appearance and their screening numbers assigned at visit 1. Subjects will enter the study site about one hour ahead of the start of allergen provocation. After positive completion of all study relevant assessments, subjects will be randomized and enter the allergy challenge chamber for 6 hours. About one hour forty-five minutes after entry (after the eighth subjective score), the first treatment with the respective nasal spray will take place under staff supervision.
The subjective nasal symptom score will be recorded every fifteen minutes during a 6-hour allergen exposure challenge. Anterior rhinomanometry will be performed regularily.
Visit 4: Day1 of second treatment period Subjects will enter the study site about one hour ahead of the start of allergen provocation. In the following Visit 4 will be done in the same way as Visit 3.
Between the respective study treatments, a wash-out period of at least 7 days must be adhered to allowing complete symptom relief from previous challenge. After the wash-out period, subjects change to the second treatment block.
During the entire trial, subjects will be asked to monitor for adverse events (AEs), and they will record the use of concomitant medications on the provided form.
One week after the final provocation session, subjects will complete the trial after their follow up visit.
The trial design is appropriate for the indication studied. Validated methods of data collection, analysis, and evaluation will be used for the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, placebo-controlled, double-blinded randomized two-way cross-over single site study in adult subjects (18 to 65 years) who demonstrate a grass pollen specific Immunoglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting Coldamaris akut nasal spray will be evaluated compared to Coldamaris sine 0.5% nasal spray.
| Arm | Type | Receives |
|---|---|---|
| Coldamaris akut | Experimental | Device: nasal sprayOne puff (140µl) into each nostril |
| Placebo | Placebo comparator | Device: nasal sprayOne puff (140µl) into each nostril |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained before any trial related procedures are performed
- Healthy male or female subjects aged 18 to 65 years
- A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years
- Subjects exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total nasal symptom score (TNSS) of at least 6 (out of 12) with the necessity to score at least "moderate = 2" for the single symptom "nasal congestion" using standard VCC grass pollen allergen mixture. Nasal symptom score is the sum of "nasal congestion", "rhinorrhea", "itchy nose" and "sneezing", each of which have been scored on a categorical scale from 0 to 3.
- Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 12 months prior to study start.
Key exclusion criteria (25 listed)
- A clinical history of uncontrolled asthma within 3 months prior to screening
- Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the
- investigator
- Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years
- Ongoing treatment with any allergen-specific immunotherapy product
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 |
|---|---|---|
| nasal sprayApplication of a nasal spray | Device | Coldamaris akut, Placebo |
Primary outcome
Nasal Congestion Symptom Score (NCSS)
Time frame: 0-6 hourse of allergen exposure challenge
calculated as the baseline adjusted mean of NCSS measured every 15 minutes during the grass pollen allergen exposure challenge from time-point 0 to 6 hours. The NCSS is scored on a 4-point scale from 0-3 with "0"= none "1"=mild "2"=moderate "3"=severe
5 secondary outcomes
Nasal airflow
Time frame: 0-6 hourse of allergen exposure challenge
Total nasal symptom score (TNSS)
Time frame: 0-6 hourse of allergen exposure challenge
Total ocular symptom score (TOSS)
Time frame: 0-3 hourse of allergen exposure challenge
Total asthma symptom score (TASS)
Time frame: 0-3 hourse of allergen exposure challenge
Nasal secretion
Time frame: 0-6 hourse of allergen exposure challenge
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 21 Feb 2021.
- Derived from this study: PubMed 39534593Unger-Manhart N, Morokutti-Kurz M, Zieglmayer P, Russo A, Siegl C, Konig-Schuster M, Koller C, Graf P, Graf C, Lemell P, Savli M, Zieglmayer R, Dellago H, Prieschl-Grassauer E. Decongestant Effect of "Coldamaris Akut", a Carrageenan- and Sorbitol-Containing Nasal Spray in Seasonal Allergic Rhinitis. Int J Gen Med. 2024 Nov 8;17:5105-5121. doi: 10.2147/IJGM.S476707. eCollection 2024.
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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.
Eva Prieschl-Grassauer, PhD study chair
CSO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal spray in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by Marinomed Biotech AG at 1 site in Austria.
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 11 inclusion and 25 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 21 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 1 site in Austria. 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. Some participants in this study may receive a placebo. 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?
Nasal Congestion Symptom Score (NCSS) (time frame: 0-6 hourse of allergen exposure challenge). 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 NCT04532762, which also lists 1 linked publication.
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 21 Feb 2021.