Efficacy and Safety of Grass Pollen Sublingual Immunotherapy
- Conditions
- Allergic Rhinoconjunctivitis
- Interventions
- Registration Number
- NCT00567346
- Lead Sponsor
- Artu Biologicals
- Brief Summary
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.
- Detailed Description
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description grass pollen extract twice weekly Oralgen 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 extract, daily Oralgen Grass pollen immunotherapy, 9,500 BU, given daily Increased dose of grass pollen extract Oralgen Increased dose of grass pollen immunotherapy, 19,000 BU, given daily Placebo control grass pollen extract Patients randomized to placebo will receive placebo daily.
- Primary Outcome Measures
Name Time Method Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS) One year
- Secondary Outcome Measures
Name Time Method Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests. one year
Trial Locations
- Locations (35)
MHAT PLovdiv, ENT Clinic
🇧🇬Plovdiv, Bulgaria
MHAT Sveta Marina
🇧🇬Varna, Bulgaria
ORL Soukroma praxe
🇨🇿Brno, Czech Republic
Svabhegyi Allami Gyermekgyogyintezet pulmonologia
🇭🇺Budapest, Hungary
Selye Janos Korhaz
🇭🇺Komarom, Hungary
Vilnius Central Outpatient Clinic
🇱🇹Vilnius, Lithuania
Karolina Korhaz
🇭🇺Mosomagyarovar, Hungary
Kaunas medical University hospital
🇱🇹Kaunas, Lithuania
Centrum imunologie a alergologie s.r.o
🇸🇰Bratislava, Slovakia
Medcentrum s.r.o.
🇸🇰Zilina, Slovakia
Ampha
🇳🇱Hengelo, Netherlands
Menox
🇳🇱Nijmegen, Netherlands
Berufsgen. kliniken Bergmannsheil
🇩🇪Bochum, Germany
Tudogyogyintezet Torokbalint
🇭🇺Torokbalint, Hungary
Privataertz. inst. & Forsh. einrichtung
🇩🇪Wiesbaden, Germany
Univ. klinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Johannes-Gutenberg-Universitat Mainz
🇩🇪Mainz, Germany
MedicoKIT
🇩🇪Goch, Germany
Klaipeda Regional Hospital
🇱🇹Klaipeda, Lithuania
Amb. klinickey imunologie a allergologie UTaRCH
🇸🇰Poprad, Slovakia
Military Medical Academy
🇧🇬Varna, Bulgaria
5th MHAT, ENT Clinic
🇧🇬Sofia, Bulgaria
Ministry of interior-central clinical database
🇧🇬Sofia, Bulgaria
Fakultni nemocnice Brno
🇨🇿Brno-Bohunice, Czech Republic
Alergologicka ordinace
🇨🇿Kutna Hora, Czech Republic
Nemocnice Caslav
🇨🇿Caslav, Czech Republic
Ambulance plicni a alergologicka
🇨🇿Ostrave - Hrabuvka, Czech Republic
FNsP Nove Zamky, ambulancia TaRCh
🇸🇰Nove Zamky, Slovakia
Vital Care
🇩🇪Muenchen, Germany
JSC Seimos gydytojas
🇱🇹Vilnius, Lithuania
Ambulancia klinickej imunologie a alergologie
🇸🇰Trencin, Slovakia
Vilnius university hospital, Santariskiu Clinic
🇱🇹Vilnius, Lithuania
Szent Janos Korhaz
🇭🇺Budapest, Hungary
Alergologicka ambulance
🇨🇿Ostrava - Hrabuvka, Czech Republic
Alergologicka ambulance Okresni nemocnice Tabor
🇨🇿Tabor, Czech Republic