Long-Term Efficacy and Safety Study With Oralgen Grass Pollen - Full Text View

Sponsored by:	Artu Biologicals
Information provided by:	Artu Biologicals
ClinicalTrials.gov Identifier:	NCT00824447

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinoconjunctivitis	Drug: Oralgen Other: placebo	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Multi-National Phase II / III Follow-up Study to Assess Long-Term Efficacy and Safety of Three Different Dose Regimens of Oralgen® Grass Pollen in Patients With Grass Pollen-Related Allergic Rhinoconjunctivitis (Follow-up Study to AB0602)

Further study details as provided by Artu Biologicals:

Primary Outcome Measures:

Pollen Season Rhinoconjunctivitis Total Symptom Score [ Time Frame: site specific pollen season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rescue medication usage [ Time Frame: one year ] [ Designated as safety issue: No ]
Proportion of symptom-free days during the pollen season [ Time Frame: one year ] [ Designated as safety issue: No ]
Rhinoconjunctivitis QoL Questionnaire [ Time Frame: one year ] [ Designated as safety issue: No ]
Global evaluation of the efficacy by the patient [ Time Frame: one year ] [ Designated as safety issue: No ]
Local and systemic tolerability and other adverse events, labor [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	356
Study Start Date:	August 2007
Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Placebo	Other: placebo
B: Active Comparator other dose of investigational drug	Drug: Oralgen allergen solution sublingually
C: Active Comparator other dose of investigational drug	Drug: Oralgen allergen solution sublingually
D: Active Comparator other dose of investigational drug	Drug: Oralgen allergen solution sublingually

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

Ages Eligible for Study:	18 Years to 51 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824447

Locations

Netherlands
AMPHA Nijmegen
Nijmegen, Netherlands, 6525EC

Sponsors and Collaborators

Artu Biologicals

Investigators

Principal Investigator:	Dyonne van Duren, MD, PhD	AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The Netherlands
Principal Investigator:	Knut Schaekel, MD, PhD	Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, Germany
Principal Investigator:	Iveta Kozlovska, MD, PhD	Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic

More Information

No publications provided

Responsible Party:	Artu Biologicals ( Dr. F.F. Roossien )
Study ID Numbers:	AB0602/1
Study First Received:	January 15, 2009
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00824447 History of Changes
Health Authority:	Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Germany: Paul-Ehrlich-Institut; Hungary: National Institute of Pharmacy; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Lithuania: State Medicine Control Agency - Ministry of Health; Slovakia: State Institute for Drug Control

Keywords provided by Artu Biologicals:

randomised
double-blind
placebo-controlled

long-term efficacy and safety
Oralgen® Grass Pollen
allergic rhinoconjunctivitis

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 07, 2009