Long-term Efficacy and Safety Study With Oralgen Grass Pollen

NCT ID: NCT00824447

Last Updated: 2010-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-01-31

Brief Summary

This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.

Detailed Description

Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma.

Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment.

Immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. At present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response.

Allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.

Conditions

Allergic Rhinoconjunctivitis

Study Design

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

Study Groups

Placebo control

Placebo control

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo control

Grass pollen extract, twice weekly

Grass pollen extract, 9,500 BU, given twice weekly

Group Type: ACTIVE_COMPARATOR

Oralgen

Intervention Type: DRUG

allergen solution sublingually

Grass pollen extract daily

Grass pollen extract, 9,500 BU, given daily

Group Type: ACTIVE_COMPARATOR

Oralgen

Intervention Type: DRUG

allergen solution sublingually

Increased dose of grass pollen extract

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

Group Type: ACTIVE_COMPARATOR

Oralgen

Intervention Type: DRUG

allergen solution sublingually

Interventions

Oralgen

allergen solution sublingually

Intervention Type: DRUG

placebo

placebo control

Intervention Type: OTHER

Other Intervention Names

grasspollen extract; Placebo control

Eligibility Criteria

Exclusion Criteria

• Patients who have given their written consent to participate in this study.
• Patients who are willing to comply with the protocol and understand the information given.
• Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
• Negative urine pregnancy test if female at the end of the previous study.

• Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
• Patients who were non-compliant during study AB0602.
• Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Artu Biologicals

INDUSTRY

Sponsor Role: lead

Responsible Party

Artu Biologicals Europe B.V.

Principal Investigators

Dyonne van Duren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The Netherlands

Knut Schaekel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, Germany

Iveta Kozlovska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic

Locations

MHAT PLovdiv, ENT Clinic

Plovdiv, , Bulgaria

Military Medical Academy, Clinic of ENT

Sofia, , Bulgaria

Military Medical Academy

Sofia, , Bulgaria

5th MHAT, ENT Clinic

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

JSC Seimos gydytojas

Vilnius, , Lithuania

Vilnius Central Outpatient Clinic

Vilnius, , Lithuania

Vilnius university hospital, Santariskiu Clinic

Vilnius, , Lithuania

Ampha Den Bosch / Regio Brabant

's-Hertogenbosch, , Netherlands

Ampha De Bilt

De Bilt, , Netherlands

Ampha

Hengelo, , Netherlands

AMPHA Nijmegen

Nijmegen, , Netherlands

Centrum imunologie a alergologie s.r.o

Bratislava, , 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

2007-002477-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AB0602/1

Identifier Type: -

Identifier Source: org_study_id