Allergic Rhinoconjunctivitis
Conditions
Brief summary
The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.
Interventions
Suspension for Injection, Every 6 weeks for one year
DRUGPlacebo
Suspension for Injection, Every 6 weeks for one year
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* A history of grass pollen allergy * Positive skin prick test to grass * Positive Immunoglobulin E test to grass
Exclusion criteria
* Other allergies overlapping the grass pollen season * Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recording of rhinoconjunctivitis symptoms | Daily recordings during the grass pollen season 2012 |
| Recording of symptomatic allergy medication use | Daily recordings during the grass pollen seasons 2012 |
Countries
Germany
Outcome results
None listed