Grass pollen induced rhinoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10039097 Term: Rhinoconjunctivitis
Conditions
Interventions
Trade Name: Grazax®
Product Name: Grazax®
Pharmaceutical Form: Oral lyophilisate
Pharmaceutical form of the placebo: Oral lyophilisate
Route of administration of the placebo: Sublingual use
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms, which remain troublesome despite treatment with anti-allergic drugs during the GPS of two years or more - A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms during GPS causing symptoms more the 4 days per week (for > 4 weeks) - A clinical history of significant persistent rhinoconjunctivitis symptoms during GPS causing least one of the a-d symptoms a. Abnormal sleep b. Impairment of daily activities, sports, leisure c. Impaired work and school d. Troublesome symptoms - Positive specific IgE against Phleum pratense (= IgE Class 2) 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
Exclusion criteria: - Uncontrolled asthma in the past 12 months - FEV1 < 70% of predicted value after adequate pharmacologic treatment - Inflammatory condition in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis - History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis - History of facial angioedema in GPS or presence of facial angioedema at time of randomization - History of swallowing difficulties in GPS or presence of swallowing difficulties at time of randomization - History of allergy symptoms in the GPS leading to hospital admission - History of allergy symptoms in the GPS leading to treatment with corticosteroids other than topical corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, based on IgE blocking antibodies.;Secondary Objective: The secondary objectives of the trial are to investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, with respect to other immunological assessments and toevaluate the tolerability of Grazax® treatment compared to placebo when initiated during the grass pollen season.;Primary end point(s): To investigate the pharmacodynamic efficacy of Grazax® compared to placebo when treatment is initiated during season, based on IgE blocking antibodies (e.g to demonstrate a lower level of IgE blocking antibodies at visit 4 (approximately 8 weeks after treatment initiation) as compared to placebo) | — |
Countries
Austria, Germany
Outcome results
None listed