A randomised, double-blind, placebo-controlled, long-term Phase III study to assess the efficacy and safety of Oralgen® Grass Pollen in patients with grass pollen-related allergic rhinoconjunctivitis.
- Conditions
- Allergic Rhinoconjunctivitis due to grass pollen allergy.
- Registration Number
- EUCTR2008-004825-40-GB
- Lead Sponsor
- Artu Biologicals Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Male or female patients aged 18 to 60 years (inclusive).
2. Grass pollen-related allergic rhinoconjunctivitis symptoms for at least the last 2 pollen seasons.
3. Positive skin prick test (wheal diameter more than 3 mm larger than the diluent control) and a grass pollen specific IgE value of at least Class II.
4. RRTSS of greater than or equal to 12 (maximum score 18) during the 2007 or 2008 pollen seasons.
5. Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
6. 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
1. Positive skin prick test for environmental allergens such as house dust mites and cockroaches, and suffering from serious allergic symptoms due to exposure to these allergens during the study period.
2. A clinical history of significant symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping, the grass pollen season.
3. A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the patient is regularly exposed.
4. Patients who lack general good health as determined by past medical history, physical examination, 12-lead ECG and safety laboratory tests.
5. 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.
6. Abnormal spirometry: Forced Expiratory Volume in 1 second (FEV1) less than 80% of the predicted value at screening.
7. A lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit.
8. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included.
9. Use of oral steroids within 12 weeks before the screening visit.
10. Treatment with beta-blockers or continuous systemic corticosteroid therapy.
11. Previous immunotherapy treatment with grass pollen or other allergen extracts within the last five years.
12. Previous treatment with Oralgen® Grass Pollen.
13. Participation in any other clinical study within the previous 30 days.
14. Positive urine pregnancy test.
15. Pregnancy, breast-feeding/lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method (see protocol)
16. 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.
17. Known infection with hepatitis B, hepatitis C or human immunodeficiency virus.
18. Patients who received blood in the previous 90 days.
19. Patients with a history of drug or alcohol abuse within the past 5 years.
20. Patients at risk of non-compliance.
21. 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
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term efficacy of 19,000 BU Oralgen® Grass Pollen administered daily in patients with grass pollen-related allergic rhinoconjunctivitis.;Secondary Objective: To assess the long-term safety and tolerability of 19,000 BU Oralgen® Grass Pollen administered daily in patients with grass pollen-related allergic rhinoconjunctivitis.;Primary end point(s): RTSS/RMS score: the combined score consisting of pollen season Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS)
- Secondary Outcome Measures
Name Time Method