Molecular and Cellular Mechanism in the Course of Immunotherapy With a Phleum Pratense Oral Lyophilisate
Condition: Allergic Rhinitis Due to Grass Pollens
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled,
      national, single-centre trial.

      The trial will be initiated before 2013 grass pollen season and subjects will be randomised
      in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo
      group will be treated 2 years with placebo and a third year with active therapy (Grazax®) and
      active group will continue the active treatment in the third year. In the last year, all
      placebo patients will be changed to active group and active and placebo patients will be
      informed about, but the trial will not be unblinded until the end of the third year and
      patients won´t know what treatment they were assigned to during the first 2 years.
    

Detailed description: 
      There is a first stage of clinical trial (GT-20) in which ALK- Abelló is directly working
      into the MEICA project to explore human immunological mechanisms of SIT (observed after
      Grazax® treatment). In this trial, different potential biomarkers of early and sustained
      effect of specific immunotherapy have been identified. Therefore, for a further research, it
      was necessary to carry on a new clinical double blind placebo control trial to evaluate a
      selected panel of biomarkers that can be applied in the selection and monitoring of patients
      during immunotherapy. They can be of value in the evaluation of future product candidates for
      specific immunotherapy. For this purpose, it is necessary that the Biomarkers selected,
      clearly differentiate between active and placebo treated groups. Moreover, specific
      immunological changes differences between active and placebo patients during pollen seasons
      are unknown. This first study allowed us identifying a potential set of biomarkers and time
      points for each of them that might correlate with treatment effect. This second study is
      needed to evaluate the potential of these biomarkers to discriminate placebo treated patients
      and it is a necessary step before incorporating them in big prospective efficacy studies.

      A third year in an active IMP design after the two years in a double blind placebo setup is
      included as a way to validate the differences observed intergroup during the first year of
      therapy. This is needed as pollen seasons significantly differ in strength and duration.
      Moreover, there is a unique opportunity of analysing immunological changes of the
      intervention before a careful baseline monitoring of patients undergoing placebo treatment,
      with the opportunity of understanding immunological clues in the natural evolution of allergy
      disease.
    

Intervention name(s): Grazax; Placebo
Intervention type(s): Drug; Other
Intervention description(s): GRAZAX; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Allergy; Phleum pratense; Rhinoconjunctivitis; asthma; positive SPT to Phleum pratense