Treatment of house dust mite induced allergic rhinoconjunctivitis
Conditions
Interventions
Product Name: Oralgen House Dust Mite
Pharmaceutical Form: Oral drops, solution
Current Sponsor code: house dust mite extract
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equa
Sponsors
Artu Biologicals Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 60 years of age (inclusive). 2. House-dust mite induced allergy with moderate to severe rhinitis symptoms for at least one year. 3. RRTSS score of greater than or equal to 10 out of a maximal score of 18. 4. Sensitized to D pter and D far as indicated by a specific RAST of at least class 2 and a positive skin prick test (i.e. wheal diameter equal to or more than 3 mm larger than the negative diluent control). 5. Positive D pter nasal provocation test at screening. 6. Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study. 7. Patients who are willing to comply with the protocol and understand the information given and the text of the consent form. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other clinically relevant allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments. Patients with allergic rhinoconjunctivitis due to allergens to which the patient is not exposed to during the study are allowed into the study. 2. Patients who lack general good health as determined by past medical history, physical examination, 12-lead ECG and safety laboratory tests. 3. Patients with a past or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of this study. 4. Abnormal spirometry: Forced Expiratory Volume in 1 second (FEV1) at least 80% of the predicted value at screening. 5. A lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit. 6. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included. 7. Use of oral steroids within 12 weeks before the screening visit. 8. Treatment with beta-blockers or continuous systemic corticosteroid therapy. 9. Previous immunotherapy treatment with house dust mite (HDM) or other allergen extracts within the last five years. 10. Participation in any other clinical study within the previous 90 days. 11. Positive urine pregnancy test. 12. Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method. 13. Patients with any nasal or ocular condition that could confound the effect assessments (for example nasal polyposis). 14. The intention to subject the patient to surgery of the nasal cavity during the current study. 15. The usual contraindications of immunotherapy such as the following: • Malignancies and oral cavity lesions recurring at least twice per year; • History of status asthmaticus and anaphylactic shock; • Aggressively developing asthmatic symptoms; • Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes; • Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis); • Auto-immune diseases and immunodeficiency; • Concurrent therapy involving immunosuppressives; • Systemic and collagen diseases; • Tuberculosis; • Serious psychological disorders; • Documented hypersensitivity to glycerol; • Use of beta-blockers; 16. Known infection with hepatitis B, hepatitis C or human immunodeficiency virus. 17. Patients who received blood in the previous 90 days. 18. Patients with a history of drug or alcohol abuse within the past 5 years. 19. Patients at risk of non-compliance. 20. Family members of investigators, co-investigators, and all the study collaborators should not be enrolled in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of different Oralgen House Dust Mite dose regimens in patients with house dust mite-related allergic rhinoconjunctivitis. ;Secondary Objective: To investigate the effect of different Oralgen House Dust Mite dose regimens on rhinoconjunctivitis symptoms and immunomarkers;Primary end point(s): Safety • Adverse events • Hematology and biochemistry laboratory parameters • Urinalysis • 12-Lead ECG • Vital signs / physical examination Effect parameters • Nasal and conjunctival provocative threshold • Nasal airflow • Nasal symptom score • Conjunctival symptom score • D pter and D far specific IgE and IgG4 (immunological markers) • D pter and D far specific skin prick test | — |
Countries
United Kingdom
Outcome results
None listed