Clinical trial NCT00567346: Efficacy and Safety of Grass Pollen Sublingual Immunotherapy
Official title: A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Rhinoconjunctivitis
Keywords: randomised
double-blind
placebo-controlled
efficacy and safety
Oralgen® Grass Pollen
allergic rhinoconjunctivitis
Allergy
Rhinoconjunctivitis
Immunotherapy
Grass pollen extract
Lead sponsor: Artu Biologicals
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
timeFrame: One year
Secondary outcomes:
measure: 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.
timeFrame: one year
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: MHAT PLovdiv, ENT Clinic
city: Sofia
country: Bulgaria
facility: 5th MHAT, ENT Clinic
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: Ministry of interior-central clinical database
city: Varna
country: Bulgaria
facility: MHAT Sveta Marina
city: Varna
country: Bulgaria
facility: Military Medical Academy
city: Brno-Bohunice
country: Czech Republic
facility: Fakultni nemocnice Brno
city: Brno
country: Czech Republic
facility: ORL Soukroma praxe
city: Caslav
country: Czech Republic
facility: Nemocnice Caslav
city: Dobruska
country: Czech Republic
facility: Alergologicka ordinace
city: Jablonec nad Nisou
country: Czech Republic
facility: Alergologicka ambulance
city: Kutna Hora
country: Czech Republic
facility: Alergologicka ordinace
city: Ostrava - Hrabuvka
country: Czech Republic
facility: Alergologicka ambulance
city: Ostrave - Hrabuvka
country: Czech Republic
facility: Ambulance plicni a alergologicka
city: Tabor
country: Czech Republic
facility: Alergologicka ambulance Okresni nemocnice Tabor
city: Bochum
country: Germany
facility: Berufsgen. kliniken Bergmannsheil
city: Dresden
country: Germany
facility: Univ. klinikum Carl Gustav Carus
city: Goch
country: Germany
facility: MedicoKIT
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universitat Mainz
city: Muenchen
country: Germany
facility: Vital Care
city: Wiesbaden
country: Germany
facility: Privataertz. inst. & Forsh. einrichtung
city: Budapest
country: Hungary
facility: Svabhegyi Allami Gyermekgyogyintezet pulmonologia
city: Budapest
country: Hungary
facility: Szent Janos Korhaz
city: Komarom
country: Hungary
facility: Selye Janos Korhaz
city: Mosomagyarovar
country: Hungary
facility: Karolina Korhaz
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Kaunas
country: Lithuania
facility: Kaunas medical University hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda Regional Hospital
city: Vilnius
country: Lithuania
facility: JSC Seimos gydytojas
city: Vilnius
country: Lithuania
facility: Vilnius Central Outpatient Clinic
city: Vilnius
country: Lithuania
facility: Vilnius university hospital, Santariskiu Clinic
city: De Bilt
country: Netherlands
facility: Ampha
city: Den Bosch
country: Netherlands
facility: Ampha
city: Hengelo
country: Netherlands
facility: Ampha
city: Nijmegen
country: Netherlands
facility: Menox
city: Bratislava
country: Slovakia
facility: Centrum imunologie a alergologie s.r.o
city: Nove Zamky
country: Slovakia
facility: FNsP Nove Zamky, ambulancia TaRCh
city: Poprad
country: Slovakia
facility: Amb. klinickey imunologie a allergologie UTaRCH
city: Trencin
country: Slovakia
facility: Ambulancia klinickej imunologie a alergologie
city: Zilina
country: Slovakia
facility: Medcentrum s.r.o.
Study officials:
affiliation: Artu-Biologicals Europe B.V., the Netherlands
name: Folkert R Roossien
role: STUDY_DIRECTOR
References: