Allergic rhinoconjunctivitis caused by grass pollen Respiratory
Conditions
Interventions
Treatment: 3 capsules (oral administration) of SYN-53 per day for 3 days after each exposure
Control: 3 capsules of placebo (oral administration) per day for 3 days after each exposure
Randomisati
Sponsors
Synformulas GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Persons of either sex between 18 and 65 years of age 2. Oral and written consent 3. Patients with clinically relevant sensitization to grass pollen and allergic symptoms for at least 2 years 4. Positive skin prick test (SPT) to grass pollen 5. Proven response to exposure to grass pollen in the AEC 6. Patients who agree to undergo all examinations and procedures mentioned in the study protocol 7. Patients who are fully conversant with the German language
Exclusion criteria
Exclusion criteria: 1. Persons under 18 years of age 2. Acute infections 3. Current cancer diagnosis/cancer within the last 5 years or autoimmune disease 4. Gastrointestinal disorders that may affect the absorption and processing of orally ingested substances, such as congenital gastrointestinal malformations or acute gastrointestinal infections 5. Severe forms of the following underlying chronic diseases: neurological diseases, metabolic diseases, severe asthma or respiratory obstruction, congenital anomalies of the heart, gastrointestinal system, or lungs 6. Patients with an FEV1 <70% (predicted value) prior to allergen exposure 7. Mental illnesses (e.g., depression) in the last 2 years 8. Eating disorders (e.g. bulimia, anorexia nervosa) in the last 2 years 9. Pregnant or breastfeeding female subjects 10. Alcohol or drug abuse 11. Clinically relevant hypersensitivity to any of the ingredients of SYN-53 12. Participation in clinical trials in the last 3 months 13. Placement in an institution due to court or official orders 14. Contraindications to epinephrine and/or other emergency medications (especially cetirizine) 15. Hyposensitization within the last 5 years against grass pollen 16. Heavy smokers (according to WHO definition more than 20 cigarettes daily) 17. Use of certain medications before V1 as well as during the study: 17.1. Decongestant nasal drops (3 days) 17.2. Antihistamines (5 days) 17.3. Anti-allergic eye drops and nasal sprays (1 week) 17.4. Topical steroids (2 weeks) 17.5. Systemic corticosteroids (3 weeks) 17.6. Probiotics (4 weeks) 17.7. Antibiotics (4 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms are measured using the Total Symptom Score (TSS, max. 24 Points) = Total Nose Symptom Score (TNSS, max. 12 Points) + Total Eye Symptom Score (TESS, max. 12 Points) at baseline and at repeated biweekly intervals (max. 3 exposures) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and at repeated biweekly intervals (max. 3 exposures) unless otherwise noted: 1. Eye Symptoms using the Max. Total Eye Symptom Score (TESS) 2. Nasal Symptoms using the Max. Total Nasal Symptom Score (TNSS) 3. Bronchial Symptoms using the Max. Total Bronchial Symptom Score (TBSS) 4. Other Symptoms using the Total Other Symptom Score (TOSS) 5. Well-being using the Visual Analogue Scale (VAS) 6. Peak Nasal Inspiratory Flow (PNIF) before and after each exposure 7. Spirometrie (FEV1, FEV1/FVC, MEF25-75) before and after each exposure 8. Amount of nasal secretion by weighing handkerchiefs before and after each exposure 9. Use of emergency medications and/or emergency case management 10. Number of incidents and number of subjects with adverse events related to ingestion of the dietary supplement SYN-53 after each exposure 11. Number of incidents and number of individuals with late reactions and/or adverse events related to exposure after each exposure | — |
Countries
Germany
Contacts
Public ContactDavid Rietbrock
Outcome results
None listed