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.
