Treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed witha positive skin-prick test and / or specific IgE test to grass pollen. MedDRA version: 15.1 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004855
Conditions
Interventions
Trade Name: GRAZAX 75000 SQ-T liofilizado oral
Product Name: Grazax
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: Extracto alergénico de polen de Phleum pratense
Other descriptive na
Sponsors
ALK-Abelló S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.A history of relevant rhinitis or rhinoconjunctivitis with or without asthma due to grass pollen since at least the pollen season prior to trial entry (GPS 2012). 2.Documented positive specific IgE against Phl p 5 (above or equal to IgE Class 2, above or equal to 0.70 kU/l). 3.Positive Skin Prick Test (SPT) response (wheal diameter above or equal 3 mm) to Phleum pratense (ALK-Abelló). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Previous treatment by immunotherapy with grass allergen extracts. 2.Ongoing treatment with any allergen specific immunotherapy product. 3.Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify changes in immunological markers measured in grass allergic subjects during treatment with Grazax.;Secondary Objective: To identify changes in immunological markers occurring at early time points during immunotherapy treatment. To identify markers which correlate with safety parameters. To identify markers which correlate with perceived efficacy as assessed by a visual analogical scale (VAS).;Primary end point(s): Immunological markers: Pre to post treatment change in immunological markers and differences versus placebo.;Timepoint(s) of evaluation of this end point: The control time is defined as: Visit 8 (2 years after treatment initiation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pre to 1 month treatment changes in immunological markers. Group comparison in changes in immunological markers in relation to (systemic) adverse reactions and VAS. Safety endpoints: Frequency of: AEs and SAEs. ESIs Vital signs;Timepoint(s) of evaluation of this end point: 1, 4, 9, 12, 21, 24, 25, 28, 33 and 36 months after treatment initiation. | — |
Countries
Spain
Contacts
Public ContactClinical Trial Assistant
ALK-Abelló S. A.
Outcome results
None listed