Demonstration of a Decongestant Effect of "Coldamaris Akut" Compared to Saline Nasal Spray.
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.

      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.
    

Intervention name(s): nasal spray
Intervention type(s): Device
Intervention description(s): Application of a nasal spray
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinoconjunctivitis; Allergic Rhinitis; Coldamaris akut; Vienna Challenge Chamber; Nasal Congestion Symptom; Carrageenan; Carragelose; Iota-carrageenan