Clinical trial NCT00824447: Long-term Efficacy and Safety Study With Oralgen Grass Pollen
Official title: A Randomised, DB, Plcb Controlled, Multicentre, Multinat. Phase II/III FU Study to Assess Longterm Efficacy and Safety of 3 Different Dose Regimens of Oralgen® GrassPollen 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
long-term efficacy and safety
Oralgen® Grass Pollen
allergic rhinoconjunctivitis
Allergy
Rhinoconjunctivitis
Immunotherapy
Grass pollen extract
Lead sponsor: Artu Biologicals
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients who meet the in and exclusion criteria for study AB0602 and successfully finished this study.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pollen Season Rhinoconjunctivitis Total Symptom Score
timeFrame: site specific pollen season
Secondary outcomes:
measure: Rescue medication usage
timeFrame: one year
measure: Proportion of symptom-free days during the pollen season
timeFrame: one year
measure: Rhinoconjunctivitis QoL Questionnaire
timeFrame: one year
measure: Global evaluation of the efficacy by the patient
timeFrame: one year
measure: Local and systemic tolerability and other adverse events, labor
timeFrame: one year
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: MHAT PLovdiv, ENT Clinic
city: Sofia
country: Bulgaria
facility: Military Medical Academy, Clinic of ENT
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: 5th MHAT, ENT Clinic
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: 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: 's-Hertogenbosch
country: Netherlands
facility: Ampha Den Bosch / Regio Brabant
city: De Bilt
country: Netherlands
facility: Ampha De Bilt
city: Hengelo
country: Netherlands
facility: Ampha
city: Nijmegen
country: Netherlands
facility: AMPHA Nijmegen
city: Bratislava
country: Slovakia
facility: Centrum imunologie a alergologie s.r.o
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: AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The Netherlands
name: Dyonne van Duren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, Germany
name: Knut Schaekel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic
name: Iveta Kozlovska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: