Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

NCT ID: NCT00567346

Last Updated: 2010-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

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.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

grass pollen extract twice weekly

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.

Group Type: ACTIVE_COMPARATOR

Oralgen

Intervention Type: DRUG

Patients will receive drops of grass pollen immunotherapy sublingually

Grass pollen extract, daily

Grass pollen immunotherapy, 9,500 BU, given daily

Group Type: ACTIVE_COMPARATOR

Oralgen

Intervention Type: DRUG

Patients will receive drops of grass pollen immunotherapy sublingually

Increased dose of grass pollen extract

Increased dose of grass pollen immunotherapy, 19,000 BU, given daily

Group Type: ACTIVE_COMPARATOR

Oralgen

Intervention Type: DRUG

Patients will receive drops of grass pollen immunotherapy sublingually

Placebo control

Patients randomized to placebo will receive placebo daily.

Group Type: PLACEBO_COMPARATOR

grass pollen extract

Intervention Type: DRUG

Patients will receive matching placebo sublingually

Interventions

Oralgen

Patients will receive drops of grass pollen immunotherapy sublingually

Intervention Type: DRUG

grass pollen extract

Patients will receive matching placebo sublingually

Intervention Type: DRUG

Other Intervention Names

grass pollen extract; Placebo control

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Artu Biologicals

INDUSTRY

Sponsor Role: lead

Responsible Party

Artu Biologicals

Principal Investigators

Folkert R Roossien

Role: STUDY_DIRECTOR

Artu-Biologicals Europe B.V., the Netherlands

Locations

MHAT PLovdiv, ENT Clinic

Plovdiv, , Bulgaria

5th MHAT, ENT Clinic

Sofia, , Bulgaria

Military Medical Academy

Sofia, , Bulgaria

Ministry of interior-central clinical database

Sofia, , Bulgaria

MHAT Sveta Marina

Varna, , Bulgaria

Military Medical Academy

Varna, , Bulgaria

ORL Soukroma praxe

Brno, , Czechia

Fakultni nemocnice Brno

Brno-Bohunice, , Czechia

Nemocnice Caslav

Čáslav, , Czechia

Alergologicka ordinace

Dobruška, , Czechia

Alergologicka ambulance

Jablonec nad Nisou, , Czechia

Alergologicka ordinace

Kutná Hora, , Czechia

Alergologicka ambulance

Ostrava - Hrabuvka, , Czechia

Ambulance plicni a alergologicka

Ostrave - Hrabuvka, , Czechia

Alergologicka ambulance Okresni nemocnice Tabor

Tábor, , Czechia

Berufsgen. kliniken Bergmannsheil

Bochum, , Germany

Univ. klinikum Carl Gustav Carus

Dresden, , Germany

MedicoKIT

Goch, , Germany

Johannes-Gutenberg-Universitat Mainz

Mainz, , Germany

Vital Care

München, , Germany

Privataertz. inst. & Forsh. einrichtung

Wiesbaden, , Germany

Svabhegyi Allami Gyermekgyogyintezet pulmonologia

Budapest, , Hungary

Szent Janos Korhaz

Budapest, , Hungary

Selye Janos Korhaz

Komárom, , Hungary

Karolina Korhaz

Mosomagyarovar, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Kaunas medical University hospital

Kaunas, , Lithuania

Klaipeda Regional Hospital

Klaipėda, , Lithuania

JSC Seimos gydytojas

Vilnius, , Lithuania

Vilnius Central Outpatient Clinic

Vilnius, , Lithuania

Vilnius university hospital, Santariskiu Clinic

Vilnius, , Lithuania

Ampha

's-Hertogenbosch, , Netherlands

Ampha

De Bilt, , Netherlands

Ampha

Hengelo, , Netherlands

Menox

Nijmegen, , Netherlands

Centrum imunologie a alergologie s.r.o

Bratislava, , Slovakia

FNsP Nove Zamky, ambulancia TaRCh

Nové Zámky, , Slovakia

Amb. klinickey imunologie a allergologie UTaRCH

Poprad, , Slovakia

Ambulancia klinickej imunologie a alergologie

Trenčín, , Slovakia

Medcentrum s.r.o.

Žilina, , Slovakia

Countries

Bulgaria; Czechia; Germany; Hungary; Lithuania; Netherlands; Slovakia

Other Identifiers

2006-001548-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AB0602

Identifier Type: -

Identifier Source: org_study_id