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

Overview

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.

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.