Effect of SYN-AR on alleviation of grass pollen allergy associated symptoms

Not Applicable

Completed

• Conditions: Allergic rhinoconjunctivitis caused by grass pollen; Eye Diseases

• Registration Number: ISRCTN15622522
• Lead Sponsor: FUTRUE R&S 2 GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-16
• Study Start: 2024-02-02
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 166

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 allergen exposure chamber
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

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 <60% (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-AR
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 baseline exposure as well as during the study. These are:
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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 after the 3-week-intervention