Allergic RhinitisNCT04531358
Demonstration of an Anti-allergic Effect in Subjects Treated With Callergin Nasal Spray in Comparison to Untreated Subjects and Subjects Treated With Vis Alpin® Alpensalz Nasal Spray, All Suffering From Grass Pollen Induced Rhinitis/Rhinoconjunctivitis
A study testing nasal spray and no treatment 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 and no treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- 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) 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
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
- Subjects with history of tuberculosis
- Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
Show all 20Show fewer
- 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 s
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ordination Dr. Petra Zieglmayer Vienna Challenge Chamber
Vienna, 1140
About this study
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.
The polymer Carragelose® is a unique broadly active anti-viral compound for treating respiratory diseases. Carragelose® is a sulfated polymer from red seaweed also widely used in the food industry and has GRAS status (FDA). The compound has a broad spectrum of anti-viral properties. Sprayed into the nose Carragelose® creates a protective layer in the nasal cavity which could prevent allergic rhinitis symptoms as well. This anti-allergic clinical performance compared to untreated subjects and to subjects treated with Vis Alpin® Alpensalz nasal spray should be demonstrated.
Read more
No clinical data in humans have been generated with Callergin so far. Callergin nasal spray is a certified Class I medical device. The use of the nasal spray is associated with a very low risk for patients. Callergin is used to moisturize nasal mucosa and to support the treatment of rhinitis of any kind. Allergic subjects could benefit from the moisturizing protective layer on the nasal mucosa, which could prevent allergen attachment to the mucosa surface.
This will be a prospective, controlled, double-blinded randomized three-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 Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects. The subjects will be treated with one puff (140 microliter) into each nostril.
The primary objective of the trial is to demonstrate an anti-allergic clinical performance of Callergin nasal spray compared to untreated subjects in grass pollen induced rhinitis/rhinoconjunctivitis. The evaluation will be based on the assessment of rhinitis symptoms during grass pollen challenge performed in the Vienna Challenge Chamber (environmental exposure chamber).
Secondary objective of the trial is to demonstrate an anti-allergic clinical performance of Callergin nasal spray compared to subjects treated with Vis Alpin® Alpensalz nasal spray.
Read the detailed description
This is a prospective, controlled, double-blinded randomized three-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 Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects.
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 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 12 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) and to the untreated control group 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 handed out their specific nasal spray. Ten to five minutes ahead of entering the grass pollen challenge chamber the treatment (nasal spray) application in the two treatment groups will take place under staff supervision. Afterwards the chamber session starts for subjective and objective assessments for a period of 3 hours.
The subjective nasal symptom score will be recorded every fifteen minutes during a 3-hour allergen exposure challenge. Every hour rhinomanometry will be performed to objectively evaluate blockage of the nose. An additional rhinomanometry will be performed 30 minutes after entry.
Visit 4: Day1 of second treatment period Subjects will enter the study site about one hour ahead of the start of allergen provocation. According to randomization number, subjects in the two treatment groups will receive the respective nasal spray. In the following Visit 4 will be done in the same way as Visit 3.
Visit 5: Day1 of third treatment period Subjects will enter the study site about one hour ahead of the start of allergen provocation. According to randomization number, subjects in the two treatment groups will receive the respective nasal spray. In the following Visit 5 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 next treatment block in the sequence.
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, no treatment
- Keywords
- Allergic Rhinoconjunctivitis, Allergic Rhinitis, Callergin, Vienna Challenge Chamber, Total Nasal Symptom Score, 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 nasal spray
no treatmentOther
no treatment
| Study group | Role | What they receive |
|---|---|---|
| Callergin | Active comparator | One puff (140 microliter) into each nostril Receives: Device: nasal spray |
| Alpin Alpensalz | Active comparator | One puff (140 microliter) into each nostril Receives: Device: nasal spray |
| no treatment | Experimental | Patients do not receive a treatment Receives: Other: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
The TNSS is the sum of the four individual symptoms
- nasal congestion
- rhinorrhoea
- itchy nose
- sneezing each scored on a 4-point categorical scale from 0-3 with "0"= none "1"=mild "2"=moderate "3"=severe
Measured: 0-3 hours of grass pollen allergen exposure challenge
Secondary outcomes (4)
Nasal airflow
Anterior nasal airflow will be assessed by rhinomanometry.
Measured: 0-3 hours of grass pollen allergen exposure challenge
Nasal secretion
Tissue weights will be used to assess nasal secretion
Measured: 0-3 hours of grass pollen 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 hours grass pollen allergen exposure challenge.
Measured: 0-3 hours of grass pollen 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 hours grass pollen allergen exposure challenge.
Measured: 0-3 hours of grass pollen 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 posted28 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
- Prospective, controlled, double-blinded randomized three-way cross-over single site study In the cross-over setting two treatments, namely Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects.
- 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
- NCT04531358
- Sponsor's protocol ID
- CAL_19_01
- Status last verified
- Oct 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 PU, Lemell P, Savli M, Zieglmayer R, Prieschl-Grassauer E. Carrageenan-Containing Nasal Spray Alleviates Allergic Symptoms in Participants with Grass Pollen Allergy: A Randomized, Controlled, Crossover Clinical Trial. Int J Gen Med. 2024 Feb 3;17:419-428. doi: 10.2147/IJGM.S447359. eCollection 2024.
PubMed 38333020
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 an Anti-allergic Effect in Subjects Treated With Callergin Nasal Spray in Comparison to Untreated Subjects and Subjects Treated With Vis Alpin® Alpensalz Nasal Spray, All Suffering From Grass Pollen Induced Rhinitis/Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT04531358
- Acronym / sponsor ID
- CAL_19_01
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- Allergic Rhinoconjunctivitis, Allergic Rhinitis, Callergin, Vienna Challenge Chamber, Total Nasal Symptom Score, 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
- 28 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.
The polymer Carragelose® is a unique broadly active anti-viral compound for treating respiratory diseases. Carragelose® is a sulfated polymer from red seaweed also widely used in the food industry and has GRAS status (FDA). The compound has a broad spectrum of anti-viral properties. Sprayed into the nose Carragelose® creates a protective layer in the nasal cavity which could prevent allergic rhinitis symptoms as well. This anti-allergic clinical performance compared to untreated subjects and to subjects treated with Vis Alpin® Alpensalz nasal spray should be demonstrated.
No clinical data in humans have been generated with Callergin so far. Callergin nasal spray is a certified Class I medical device. The use of the nasal spray is associated with a very low risk for patients. Callergin is used to moisturize nasal mucosa and to support the treatment of rhinitis of any kind. Allergic subjects could benefit from the moisturizing protective layer on the nasal mucosa, which could prevent allergen attachment to the mucosa surface.
This will be a prospective, controlled, double-blinded randomized three-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 Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects. The subjects will be treated with one puff (140 microliter) into each nostril.
The primary objective of the trial is to demonstrate an anti-allergic clinical performance of Callergin nasal spray compared to untreated subjects in grass pollen induced rhinitis/rhinoconjunctivitis. The evaluation will be based on the assessment of rhinitis symptoms during grass pollen challenge performed in the Vienna Challenge Chamber (environmental exposure chamber).
Secondary objective of the trial is to demonstrate an anti-allergic clinical performance of Callergin nasal spray compared to subjects treated with Vis Alpin® Alpensalz nasal spray.
Detailed description
This is a prospective, controlled, double-blinded randomized three-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 Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects.
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 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 12 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) and to the untreated control group 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 handed out their specific nasal spray. Ten to five minutes ahead of entering the grass pollen challenge chamber the treatment (nasal spray) application in the two treatment groups will take place under staff supervision. Afterwards the chamber session starts for subjective and objective assessments for a period of 3 hours.
The subjective nasal symptom score will be recorded every fifteen minutes during a 3-hour allergen exposure challenge. Every hour rhinomanometry will be performed to objectively evaluate blockage of the nose. An additional rhinomanometry will be performed 30 minutes after entry.
Visit 4: Day1 of second treatment period Subjects will enter the study site about one hour ahead of the start of allergen provocation. According to randomization number, subjects in the two treatment groups will receive the respective nasal spray. In the following Visit 4 will be done in the same way as Visit 3.
Visit 5: Day1 of third treatment period Subjects will enter the study site about one hour ahead of the start of allergen provocation. According to randomization number, subjects in the two treatment groups will receive the respective nasal spray. In the following Visit 5 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 next treatment block in the sequence.
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
- 3
- Model description
- Prospective, controlled, double-blinded randomized three-way cross-over single site study In the cross-over setting two treatments, namely Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects.
| Arm | Type | Receives |
|---|---|---|
| Callergin | Active comparator | Device: nasal sprayOne puff (140 microliter) into each nostril |
| Alpin Alpensalz | Active comparator | Device: nasal sprayOne puff (140 microliter) into each nostril |
| no treatment | Experimental | Other: no treatmentPatients do not receive a treatment |
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) 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 (20 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
- Subjects with history of tuberculosis
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 nasal spray | Device | Alpin Alpensalz, Callergin |
| no treatmentno treatment | Other | no treatment |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: 0-3 hours of grass pollen allergen exposure challenge
The TNSS is the sum of the four individual symptoms * nasal congestion * rhinorrhoea * itchy nose * sneezing each scored on a 4-point categorical scale from 0-3 with "0"= none "1"=mild "2"=moderate "3"=severe
4 secondary outcomes
Nasal airflow
Time frame: 0-3 hours of grass pollen allergen exposure challenge
Nasal secretion
Time frame: 0-3 hours of grass pollen allergen exposure challenge
Total ocular symptom score (TOSS)
Time frame: 0-3 hours of grass pollen allergen exposure challenge
Total asthma symptom score (TASS)
Time frame: 0-3 hours of grass pollen 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 38333020Unger-Manhart N, Morokutti-Kurz M, Zieglmayer PU, Lemell P, Savli M, Zieglmayer R, Prieschl-Grassauer E. Carrageenan-Containing Nasal Spray Alleviates Allergic Symptoms in Participants with Grass Pollen Allergy: A Randomized, Controlled, Crossover Clinical Trial. Int J Gen Med. 2024 Feb 3;17:419-428. doi: 10.2147/IJGM.S447359. eCollection 2024.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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 and no treatment 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 20 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. 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: 0-3 hours of grass pollen 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 NCT04531358, 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.