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
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional

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.
    

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.
    

Intervention name(s): nasal spray; no treatment
Intervention type(s): Device; Other
Intervention description(s): application of nasal spray; no treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinoconjunctivitis; Allergic Rhinitis; Callergin; Vienna Challenge Chamber; Total Nasal Symptom Score; Carrageenan; Carragelose; Iota-carrageenan