Long-term Efficacy and Safety Study With Oralgen Grass Pollen

Allergic Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824447
• Other study ID #: AB0602/1
• Secondary ID: 2007-002477-31
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 15, 2009
• Last updated: May 4, 2010
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: May 2010
• Source: Artu Biologicals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Lithuania: State Medicine Control Agency - Ministry of HealthSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 51 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Oralgen
allergen solution sublingually

Other:
• placebo
placebo control

Locations

Country	Name	City	State
Bulgaria	MHAT PLovdiv, ENT Clinic	Plovdiv
Bulgaria	5th MHAT, ENT Clinic	Sofia
Bulgaria	Military Medical Academy	Sofia
Bulgaria	Military Medical Academy, Clinic of ENT	Sofia
Bulgaria	Ministry of interior-central clinical database	Sofia
Bulgaria	MHAT Sveta Marina	Varna
Bulgaria	Military Medical Academy	Varna
Czech Republic	ORL Soukroma praxe	Brno
Czech Republic	Fakultni nemocnice Brno	Brno-Bohunice
Czech Republic	Nemocnice Caslav	Caslav
Czech Republic	Alergologicka ordinace	Dobruska
Czech Republic	Alergologicka ambulance	Jablonec nad Nisou
Czech Republic	Alergologicka ordinace	Kutna Hora
Czech Republic	Alergologicka ambulance	Ostrava - Hrabuvka
Czech Republic	Ambulance plicni a alergologicka	Ostrave - Hrabuvka
Czech Republic	Alergologicka ambulance Okresni nemocnice Tabor	Tabor
Germany	Berufsgen. kliniken Bergmannsheil	Bochum
Germany	Univ. klinikum Carl Gustav Carus	Dresden
Germany	MedicoKIT	Goch
Germany	Johannes-Gutenberg-Universitat Mainz	Mainz
Germany	Vital Care	Muenchen
Germany	Privataertz. inst. & Forsh. einrichtung	Wiesbaden
Hungary	Svabhegyi Allami Gyermekgyogyintezet pulmonologia	Budapest
Hungary	Szent Janos Korhaz	Budapest
Hungary	Selye Janos Korhaz	Komarom
Hungary	Karolina Korhaz	Mosomagyarovar
Hungary	Tudogyogyintezet Torokbalint	Torokbalint
Lithuania	Kaunas medical University hospital	Kaunas
Lithuania	JSC Seimos gydytojas	Vilnius
Lithuania	Vilnius Central Outpatient Clinic	Vilnius
Lithuania	Vilnius university hospital, Santariskiu Clinic	Vilnius
Netherlands	Ampha Den Bosch / Regio Brabant	's-Hertogenbosch
Netherlands	Ampha De Bilt	De Bilt
Netherlands	Ampha	Hengelo
Netherlands	AMPHA Nijmegen	Nijmegen
Slovakia	Centrum imunologie a alergologie s.r.o	Bratislava
Slovakia	Amb. klinickey imunologie a allergologie UTaRCH	Poprad
Slovakia	Ambulancia klinickej imunologie a alergologie	Trencin
Slovakia	Medcentrum s.r.o.	Zilina

Sponsors (1)

Lead Sponsor	Collaborator
Artu Biologicals

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Germany,  Hungary,  Lithuania,  Netherlands,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pollen Season Rhinoconjunctivitis Total Symptom Score		site specific pollen season	No
Secondary	Rescue medication usage		one year	No
Secondary	Proportion of symptom-free days during the pollen season		one year	No
Secondary	Rhinoconjunctivitis QoL Questionnaire		one year	No
Secondary	Global evaluation of the efficacy by the patient		one year	No
Secondary	Local and systemic tolerability and other adverse events, labor		one year	No