Status:
COMPLETED
Molecular and Cellular Mechanism in the Course of Immunotherapy With a Phleum Pratense Oral Lyophilisate
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Allergic Rhinitis Due to Grass Pollens
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 wil...
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...
Eligibility Criteria
Inclusion
- A history of grass pollen allergy
- Positive skin prick test to grass
- Positive specific IgE against Phl p 5
- Written informed consent before entering the trial.
- Female subjects who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods.
- Subject willing and able to comply with the trial protocol.
Exclusion
- Previous treatment by immunotherapy with grass allergen extracts.
- Ongoing treatment with any allergen specific immunotherapy product.
- Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.
- Use of medication at the screening visit which can interfere with SPT results
- A clinical history of symptomatic perennial allergic rhinitis or asthma.
- History of allergy, hypersensitivity or intolerance to the excipients of IMP (except for Phleum pratense).
- Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease).
- Any clinically relevant chronic disease (≥ 3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency).
- Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation.
- FEV1 ≤ 70% of predicted value.
- Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation.
- Being immediate family of the investigator or trial staff.
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
- Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
- Use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01854736
Start Date
April 1 2013
End Date
December 1 2015
Last Update
June 28 2017
Active Locations (2)
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1
Hospital Universitario de La Princesa
Madrid, Spain, 28006
2
Hospital Clínico Universitario San Carlos
Madrid, Spain, 28040