Allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Product Name: Trichuris suis ova
Product Code: TSO
Pharmaceutical Form: Oral suspension
Concentration unit: ml millilitre(s)
Concentration type: range
Concentration number: 150-183
Pharmaceutical form
Sponsors
Statens Serum Institut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged >18 and 70% of expected. 4. Scoring all symptoms of allergic rhinitis >50 mm on a 100 mm VAS (0=not bothersome, 10=worst) 5. Specific IgE class >2 to birch and/or grass (>0.7 kUallergen/l) 6. A positive skin prick test (>3mm) to birch and/or grass 7. Women must not be pregnant, and women in fertile age must have a negative pregnancy test, not be breastfeeding, and use birth control during the trial unless sterile or post meno-pausal 8. Prepared to grant authorized persons access to medical records 9. The volunteer is likely to comply with instructions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Significant asthma 2. Use of systemic steroids during the last 2 months 3. Immune therapy for birch or grass pollen allergy the last 2 years, or more. 4. Planning a travel abroad during the trial period (excluding areas with a similar grass/birch pollen counts when compared with the Copenhagen area) 5. Past or current severe diseases (a history of active hepatitis B or C, cytomegalovirus, herpes simplex, HIV, other kinds of immune deficiency, and cancer) 6. Anti-helminth treatment within the last 2 weeks (e.g mebendazol) 7. Known or possible hypersensitivity to Trichuris species or compounds made of Trichuris species 8. A past or recent drug abuse 9. Participation in other clinical trials 10. Employed with the Investigator (Pulmonology- and Allergy Clinic Copenhagen (center of trial)), or the relevant department at the sponsor institution (Department of Epidemiology Research at Statens Serum Institut).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of transient Trichuris suis infestation of the gut on self-reported symptoms of allergic rhinitis and number of well-days among adults with allergic rhinitis.;Secondary Objective: To assess the efficacy and safety of transient Trichuris suis infestation of the gut on allergic rhinitis and asthma assessed through self-reported disease activity, clinical skin and airway activity, and immunological activity among adults with allergic rhinitis.;Primary end point(s): Daily score for symptoms of allergic rhinitis, and number of well days during the pollen season. | — |
Countries
Denmark
Outcome results
None listed