Allergic Rhinitis Due to Grass Pollens Clinical Trial
Official title:
Molecular and Cellular Mechanism in the Course of Immunotherapy With a Phleum Pratense Oral Lyophilisate
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01889875 -
Immunological Comparison of AIT and SCIT Immunotherapy Against Grass Pollen
|
N/A | |
| Terminated |
NCT02041624 -
International Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis
|
N/A |