Efficacy and Safety of Grass Pollen Sublingual Immunotherapy
Allergic Rhinoconjunctivitis
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, Allergy, Rhinoconjunctivitis, Immunotherapy, Grass pollen extract
Eligibility Criteria
Inclusion Criteria:
- male or female aged 18-50
- patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
- Positive skin prick test and IgE value of at least Class 2+
- RTSS of greater or equal to 14 during pollen season prior tot the start of the study
- Patients must be in general good health
- Patients with normal spirometry
- Informed consent given and willing to comply with the protocol
- Female patients are eligible if they use an accepted contraceptive method
- Negative urine pregnancy test if female
Exclusion Criteria:
- Pregnancy, breast feeding
- Asthma requiring treatment other than beta-2 inhaled agonists
- patients who have taken oral steroids within 12 weeks before screening visit
- patients who have received desensitisation treatment for grass pollen
- treatment by immunotherapy with any other allergen within the previous 5 years
- patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
- patients at risk of non-compliance
- participation in any other clinical study within the previous 3 months
- patients with a past or current disease, which may affect participation in or outcome of this study.
- patients treated with beta-blockers or under continuous corticotherapy
- allergic sensitivity to epithelial allergens the patients is exposed to
- positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
- intention to subject the patient to surgery of the nasal cavity during current study
- Usual contraindications of immunotherapy
- a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season
Sites / Locations
- MHAT PLovdiv, ENT Clinic
- 5th MHAT, ENT Clinic
- Military Medical Academy
- Ministry of interior-central clinical database
- MHAT Sveta Marina
- Military Medical Academy
- Fakultni nemocnice Brno
- ORL Soukroma praxe
- Nemocnice Caslav
- Alergologicka ordinace
- Alergologicka ambulance
- Alergologicka ordinace
- Alergologicka ambulance
- Ambulance plicni a alergologicka
- Alergologicka ambulance Okresni nemocnice Tabor
- Berufsgen. kliniken Bergmannsheil
- Univ. klinikum Carl Gustav Carus
- MedicoKIT
- Johannes-Gutenberg-Universitat Mainz
- Vital Care
- Privataertz. inst. & Forsh. einrichtung
- Svabhegyi Allami Gyermekgyogyintezet pulmonologia
- Szent Janos Korhaz
- Selye Janos Korhaz
- Karolina Korhaz
- Tudogyogyintezet Torokbalint
- Kaunas medical University hospital
- Klaipeda Regional Hospital
- JSC Seimos gydytojas
- Vilnius Central Outpatient Clinic
- Vilnius university hospital, Santariskiu Clinic
- Ampha
- Ampha
- Ampha
- Menox
- Centrum imunologie a alergologie s.r.o
- FNsP Nove Zamky, ambulancia TaRCh
- Amb. klinickey imunologie a allergologie UTaRCH
- Ambulancia klinickej imunologie a alergologie
- Medcentrum s.r.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
grass pollen extract twice weekly
Grass pollen extract, daily
Increased dose of grass pollen extract
Placebo control
Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given.
Grass pollen immunotherapy, 9,500 BU, given daily
Increased dose of grass pollen immunotherapy, 19,000 BU, given daily
Patients randomized to placebo will receive placebo daily.