A double-blind, randomised, placebo controlled, phase I/IIa dose escalation study to investigate the safety and the effect of different doses of Oralgen House Dust Mite in patients with house dust mite induced allergic rhinoconjunctivitis

• Conditions: Treatment of house dust mite induced allergic rhinoconjunctivitis

• Registration Number: EUCTR2008-003879-49-GB
• Lead Sponsor: Artu Biologicals Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified