children from 5 to 18 years with grass pollen induced rhinoconjunctivitis with/without controlled asthma MedDRA version: 9.1 Level: LLT Classification code 10054928
Conditions
Interventions
Trade Name: GRAZAX
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: Grass pollen
Concentration unit: SQU Standardised Quality Unit(s) (Deprecated)
Concentration type: equal
Concentration nu
Sponsors
ALK-ABELLO`
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Boys and girls 5-18 years of age 2. Written informed consent obtained from parents/guardians and from subjects if the level of intellectual maturity makes it appropriate. Assent will be obtained from subjects turning 18 during the trial. 3. A clinical history of grass pollen induced allergic rhinoconjunctivitis with controlled or partly controlled asthma having received treatment during the previous grass pollen season. 4. Positive Skin Prick Test (SPT) response (wheal diameter > 3 mm) to Phleum pratense 5. Positive specific IgE against Phleum pratense( >IgE Class 2 ) 6. Female subject who are fertile, must have a negative pregnancy test. In case of female subjects adequate methods to avoid pregnancy should be used. (in case of pregnancy the subject will stop to take study medication and will be followed until delivery) 7. Subject and parent/guardian willing and able to comply with trial protocol regimens. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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. A clinical history of symptomatic seasonal allergic rhinitis and asthma, having received regular medication, due to another allergen during-or potentially overlapping- the grass pollen season 2. A clinical history of perennial allergic rhinitis and asthma having received regular medication due to an allergen to which the subject is regular exposed. 3. A clinical history of chronic sinusitis during the last 2 years. 4. A clinical history of severe asthma and/or a FEV1 <80% 5. Any clinical relevant chronic disease such as hepatic or renal insufficiency, immunological diseases (Rheumatoid arthritis, lymphoma ect) 6. Current severe atopic dermatitis 7. Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years 8. History of anaphylaxis 9. Chronic urticaria and angioedema. 10. Immunosuppressive treatments (cyclosporine and other immunomodulating drugs such as metothrexate, azathioprine ) (except for steroids for allergic symptoms) 11. History of allergy, hypersensitivity or intolerance to investigational medicinal product ( except for Phleum pratense) or rescue medications 12. Unlike to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period. 13. Being immediate family of the Investigator or trial staff, defined as the investigators/staffs child or grandchild.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint will be the comparison between the two groups of the total number of days with severe symptoms during the pollen season after 3 years of treatment (pollen season 2012). A total of 6 rhinoconjunctivitis symptoms should be measured on a scale from 0-3 (patients diary).According to Durham et al, (EAACI 2008) and Bufe et al (JACI 2009) using therefore a symptom score (SS) with a scale ranging from 0 to 18, (6 items) a day with severe symptom will be defined as a day with a SS ≥10, despite the use of rescue medications. SS would be measured with a patient diary card during the entire pollen season.;Main Objective: To evaluate the 3 years efficacy, tolerability, safety of specific immunotherapy with Grazax compared to placebo on the top of rescue allergic symptomatic drugs in children with grass pollen induced rhinoconjunctivitis with or without controlled or partly controlled asthma.;Secondary Objective: total number of days with severe symptoms during the 1, 2 and 3rd years of treatment (pollen season 2010, 2011 and 2012) -the average rhinoconjunctivitis symptom score and medication score in the entire grass pollen season during 1, 2 and 3 years - the average rhinoconjunctivitis symptoms in the peak grass pollen season by VAS during 1,2 and 3 years of treatment -recording of all adverse events and all SAE -the average asthma medication symptom score in the entire grass pollen season and in the peak pollen season. A total of 4 asthma symptoms should be measured on a scale from 0 to 3. -findings from physical examination, vital signs and FEV1 as well as monitoring of hematology, blood chemistry and urine values. -Profilin sensitization with SPT with Palm profiling | — |
Countries
Italy
Outcome results
None listed