E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic Rhinoconjunctivitis due to grass pollen allergy. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the long-term efficacy of 19,000 BU Oralgen® Grass Pollen administered daily in patients with grass pollen-related allergic rhinoconjunctivitis. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
|
E.4 | Principal exclusion criteria |
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
RTSS/RMS score: the combined score consisting of pollen season Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 56 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of trial is when the last patient has completed the follow-up visit (i.e. the last visit of the trial). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |