Grass pollen induced rhinoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10039097 Term: Rhinoconjunctivitis
Conditions
Interventions
Trade Name: GRAZAX®
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: Allergens of Phleum Pratense
CAS Number: 8000045252
Other descriptive name: ALLERGENS, POLLEN & PLANT EXTRACT
Concentrat
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season. 2. Reporting of treatment related allergic adverse events (local reactions in mouth and throat) after intake of Grazax at screening (visit 1). 3. Positive Skin Prick Test (SPT) response (wheal diameter = 3 mm larger than the negative control with a flare) to Phleum pratense. 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: 1. Uncontrolled asthma in the past 12 months 2. FEV1 < 70% of predicted value (calculated according to (21)) 3. A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to another allergen which may cause symptoms during the conduct of this trial 4. A clinical history of significant symptomatic perennial rhinitis or allergic rhinitis/asthma caused by an allergen to which the subject is regularly exposed 5. At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media is not an exclusion criterion) 6. History of emergency visit or admission for asthma in the previous 12 months 7. History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis 8. History of allergy, hypersensitivity or intolerance to IMPs (except for Phleum pratense) or Desloratadine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate whether intake of antihistamine in connection with Grazax treatment results in a reduction in number of subjects reporting treatment related AEs the first day of Grazax exposure. ;Secondary Objective: None.;Primary end point(s): The primary endpoint is reduction in number of subjects reporting AEs during treatment with Grazax in combination with Aerius compared to treatment with Grazax in combination with placebo. | — |
Countries
Germany
Outcome results
None listed