Long-term Efficacy and Safety Study With Oralgen Grass Pollen

This study has been completed.
Sponsor:
Information provided by:
Artu Biologicals
ClinicalTrials.gov Identifier:
NCT00824447
First received: January 15, 2009
Last updated: May 4, 2010
Last verified: May 2010
  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 2
Phase 3

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

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
Placebo Comparator: Placebo control
Placebo control
Other: placebo
placebo control
Other Name: Placebo control
Active Comparator: Grass pollen extract, twice weekly
Grass pollen extract, 9,500 BU, given twice weekly
Drug: Oralgen
allergen solution sublingually
Other Name: grasspollen extract
Active Comparator: Grass pollen extract daily
Grass pollen extract, 9,500 BU, given daily
Drug: Oralgen
allergen solution sublingually
Other Name: grasspollen extract
Active Comparator: Increased dose of grass pollen extract
Increased dose of grass pollen extract, 19,000 BU, given daily
Drug: Oralgen
allergen solution sublingually
Other Name: grasspollen extract

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

  Show 39 Study Locations
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: Dr. F.F. Roossien, Artu Biologicals Europe B.V.
ClinicalTrials.gov Identifier: NCT00824447     History of Changes
Other Study ID Numbers: AB0602/1, 2007-002477-31
Study First Received: January 15, 2009
Last Updated: May 4, 2010
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
Allergy
Rhinoconjunctivitis
Immunotherapy
Grass pollen extract

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014