Grass pollen induced allergic rhinoconjunctivitis with or without asthma. MedDRA version: 14.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: AVANZ Phleum pratense
Product Code: AVANZ Phleum pratense
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: 225
Other descripti
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults with documented clinically relevant history of grass pollen induced allergic rhinoconjunctivitis with or without asthma despite having received symptomatic treatment during the grass pollen seasons 2010 and 2011 - A clinical history of severe rhinoconjunctivitis interfering with usual activities or sleep, and subjects who experience an appropriate minimum level of symptoms (defined as a rhinoconjunctivitis DSS score of >/= 10 on the worst day of the previous GPS season) prior to randomisation can be enrolled. - Positive SPT response to Phleum Pratense - Positive specific IgE against Phleum pratense. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis caused by an allergen, other than grass, overlapping the grass pollen season. - Asthma with reduced lung function defined as FEV-1 <70% of predicted value after adequate pharmacologic treatment. - Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of two dosing schedules of Avanz Phleum pratense compared to placebo in subjects suffering from grass pollen induced allergic rhinoconjunctivitis with or without asthma. The evaluation is based on the combined rhinoconjunctivitis daily symptoms score (DSS) and rhinoconjunctivitis daily medication score (DMS) during the entire grass pollen season (GPS).;Secondary Objective: - To compare efficacy between the two dosing schedules of Avanz Phleum pratense and placebo with respect to the average rhinoconjunctivitis DSS and DMS for the entire GPS - To assess overall safety - To compare the two dosing schedules of Avanz Phleum pratense and placebo with respect to: Immunological parameters Pharmacoeconomic parameters Quality of life (QOL) Asthma symptoms and medication in the grass pollen season.;Primary end point(s): - The combined (sum of) rhinoconjunctivitis DSS and DMS averaged over the entire GPS - The combined score for each subject is calculated as the sum of rhinoconjunctivitis DSS and DMS during the entire GPS divided by the number of days with diary records in the entire GPS (=S(DSS+DMS)/(Records in GPS)). ;Timepoint(s) of evaluation of this end point: Database lock | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The average rhinoconjunctivitis DSS for the entire GPS, calculated for each subject as the sum of the rhinoconjunctivitis DSS during the entire GPS devided by the number of days with diary records in the entire GPS. - The average rhinoconjunctivitis DMS for the entire GPS, calculated for each subject as the sum of the rhinoconjunctivitis DMS during the entire GPS divided by the number of days with diary records in the entire GPS.;Timepoint(s) of evaluation of this end point: Database lock | — |
Countries
Austria, Germany, Spain
Contacts
Public ContactClinical Development
ALK-Abelló A/S
Outcome results
None listed