Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT04531358
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2020-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Marinomed Biotech AG
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: