Randomised, double-blind, placebo-controlled, multinational, multi-centre, Phase IIb / III study of the efficacy and safety of three doses of sublingual immunotherapy (SLIT) administered as tablets once daily to patients suffering from grass pollen rhinoconjunctivitis

• Conditions: Grass Pollen Related Allergic Rhinoconjunctivitis; MedDRA version: 7.0Level: PTClassification code 10010744

• Registration Number: EUCTR2004-001910-15-DK
• Lead Sponsor: Stallergenes S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Male or female outpatients, aged 18 to 45 years (inclusive).
2. Patients with documented grass pollen-related allergic rhinoconjunctivitis for at least 2 years (last 2 pollen seasons).
3. Patients who have been informed of the nature and aims of the study and have given their written consent / assent to participate in this study in accordance with local laws and requirements (refer to Appendix 3).
4. Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ.
5. Positive SPT (wheal diameter greater than 3 mm) and positive RAST (greater than or equal to Class 2) for grass pollen.
6.A score of greater than or equal to 12 on the RRTSS. (Evaluation of the most severe symptoms during the previous pollen season).

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. Allergic rhinoconjunctivitis due to a cosensitisation likely to significantly change the symptoms of the patient throughout the study or patients who have symptoms of rhinoconjunctivitis during the Treatment Phase due to sensitisation to allergens other than the grass pollens.
2. Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
3. Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating nasal or systemic corticoid treatment may be included.
4. Patients who have received desensitisation treatment for grass pollen.
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. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
6. Patients treated with beta-blockers or under continuous corticotherapy.
7. Treatment by immunotherapy with another allergen within the previous 5 years.

Study & Design

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