A randomised, double-blind, placebo-controlled, multi-national, multi-centre, phase III extension study to assess the long term efficacy, safety and carry-over effect of one dose of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis

Phase 1

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

• Registration Number: EUCTR2005-002501-23-SK
• Lead Sponsor: Stallergenes S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-05
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 628

Inclusion Criteria

1. Male or female outpatients, aged 18-46 years (inclusive)
2. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
3. Sensitised to grass pollen (positive SPT and IgE level of at least Class 2)
4. Total symptom score on the RRTSS during the pollen season prior to the start of the V034.04 study of greater than or equal to 12.
5. Patients who are willing to comply with the protocol.
6. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
7. 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.
8. Patients must have been compliant with respect to the completion of the daily record card and taking of the investigational product during study V034.04.

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 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 child-bearing 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 inhaled or systemic corticoid treatment may be included.
4. Patients who have taken oral steroids 4 weeks prior to enrolment in this study.
5. Patients who have received desensitisation treatment for grass pollen (other than study V034.04).
6. Patients at risk of non-compliance.
7. Participation in any other clinical study since end of V034.04.
8. Patients with a new or current disease, which as judged by the investigator, may affect the patient’s participation in or the outcome of the study. These diseases include, but are not limited to, cardiovascular disease, malignanacy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
9. Patients treated with beta-blockers since end of V034.04.

Study & Design

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