J30.1
Conditions
Interventions
Group 1: Single dose of AM-301 before pollen chamber at visit 6 and single dose of comparator product (HPMC) before pollen chamber at visit 8 at an interval of 7 days.
1 spray of each product (AM-301:
Sponsors
Altamira Medica AG
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria: - Women and men aged 18-65 years. Women may be included only if they are not pregnant and, in addition, are either not of childbearing potential or are using a safe method of contraception - BMI between 18 and 32 kg/m2 - History of seasonal allergic rhinitis to grass pollen - Positive skin prick test for Dactylis glomerata (alternatively sweetgrass mixture, including D. glomerata) at screening or within 12 months prior to screening visit - Normal lung function (FEV1 = 80 % pred. and FEV1/FVC = 70%) at screening - Adequate level of rhinitis symptoms in a grass pollen challenge, defined as a TNSS of at least 6 (out of 12) at two times within the 4-hour screening grass pollen challenge
Exclusion criteria
Exclusion criteria: Main Exclusion criteria: - Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinanalysis, vital signs, lung function or 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 - Past or present concomitant medical conditions, 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). - Allergen specific Immunotherapy (SIT) within 2 years prior to the study - Any upper respiratory tract infection (including rhinitis and sinusitis) in the last 14 days before entering the study - Asthma requiring more than inhaled short-acting beta-2 agonists (Step 2 or more severe asthma consistent with steps defined in Global Initiative for Asthma, Global Strategy for Asthma Management and Prevention, 2019). - History of an acute infection four weeks prior to the informed consent visit - Subjects with severe septum deviation or other structural nasal abnormalities that prevent the intranasal administration of a medical device - Subject has a positive result for SARS-CoV-2 PCR test at screening and before any clinical investigation related allergen challenge - Subject has clinical signs and symptoms consistent with COVID-19 infection, e.g., fever, dry cough, dyspnea, sore throat, fatigue, muscle or body aches and gastrointestinal symptoms or confirmed infection by appropriate SARS-CoV-2 PCR test within the 4 weeks prior to visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in mean TNSS values after 240 min of pollen exposure in the pollen chamber (0-240 min) between AM-301 and comparator product (HPMC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in weight of nasal secretion during pollen exposure in pollen chamber (0-240 min) between AM-301 and comparator product (HPMC) | — |
Countries
Germany
Contacts
Public ContactUte Langanki-Bittkau oder Ritzer
Fraunhofer ITEM
Outcome results
None listed