Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms

Exclusion Criteria

• •1\. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urine analysis, vital signs, lung function or Electrocardiogram (ECG) at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study
• •2\. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
• •3\. History of an acute infection four weeks prior to the informed consent visit
• •4\. Specific Immunotherapy (SIT) within 2 years prior to the study
• •5\. Rhinitis of other cause, chronic sinusitis or rhinitis or sinusitis in the last 14 days before entering the study
• •6\. Asthma requiring more than inhaled short-acting beta-2 agonists.
• •7\. Conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ACC for 4 hours.
• •8\. Any contraindication for adrenalin use (e.g. use of local and systemic beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors
• •9\. Treatment with antipsychotic medications with antihistaminic effect (e.g. chlorpromazine, levomepromazine, clozapine, olanzapine, tioridazine)
• •10\. Use of any medications according to section 8.2 in the period indicated before allergen challenge
• •11\. Participation in another clinical trial 30 days prior to enrollment.
• •12\. History of drug or alcohol abuse
• •13\. Risk of non-compliance with study procedures
• •14\. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study