Long-term Efficacy and Safety Study With Oralgen Grass Pollen

May 4, 2010 updated by: Artu Biologicals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria
        • MHAT PLovdiv, ENT Clinic
      • Sofia, Bulgaria, 1606
        • Military Medical Academy
      • Sofia, Bulgaria, 1606
        • Military Medical Academy, Clinic of ENT
      • Sofia, Bulgaria
        • 5th MHAT, ENT Clinic
      • Sofia, Bulgaria
        • Ministry of interior-central clinical database
      • Varna, Bulgaria
        • MHAT Sveta Marina
      • Varna, Bulgaria
        • Military Medical Academy
  • Czech Republic
      • Brno, Czech Republic
        • ORL Soukroma praxe
      • Brno-Bohunice, Czech Republic
        • Fakultní Nemocnice Brno
      • Caslav, Czech Republic
        • Nemocnice Caslav
      • Dobruska, Czech Republic
        • Alergologicka ordinace
      • Jablonec nad Nisou, Czech Republic, 466 04
        • Alergologicka ambulance
      • Kutna Hora, Czech Republic, 284 01
        • Alergologicka ordinace
      • Ostrava - Hrabuvka, Czech Republic
        • Alergologicka ambulance
      • Ostrave - Hrabuvka, Czech Republic
        • Ambulance plicni a alergologicka
      • Tabor, Czech Republic
        • Alergologicka ambulance Okresni nemocnice Tabor
  • Germany
      • Bochum, Germany
        • Berufsgen. kliniken Bergmannsheil
      • Dresden, Germany
        • Univ. klinikum Carl Gustav Carus
      • Goch, Germany
        • MedicoKIT
      • Mainz, Germany
        • Johannes-Gutenberg-Universität Mainz
      • Muenchen, Germany
        • Vital Care
      • Wiesbaden, Germany
        • Privataertz. inst. & Forsh. einrichtung
  • Hungary
      • Budapest, Hungary
        • Svabhegyi Allami Gyermekgyogyintezet pulmonologia
      • Budapest, Hungary
        • Szent János Kórház
      • Komarom, Hungary
        • Selye János Kórház
      • Mosomagyarovar, Hungary
        • Karolina Korhaz
      • Torokbalint, Hungary
        • Tudogyogyintezet Torokbalint
  • Lithuania
      • Kaunas, Lithuania
        • Kaunas Medical University Hospital
      • Vilnius, Lithuania
        • JSC Seimos gydytojas
      • Vilnius, Lithuania
        • Vilnius Central Outpatient Clinic
      • Vilnius, Lithuania
        • Vilnius university hospital, Santariskiu Clinic
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5233 VG
        • Ampha Den Bosch / Regio Brabant
      • De Bilt, Netherlands, 3731 DN
        • Ampha De Bilt
      • Hengelo, Netherlands
        • Ampha
      • Nijmegen, Netherlands, 6525EC
        • AMPHA Nijmegen
  • Slovakia
      • Bratislava, Slovakia
        • Centrum imunologie a alergologie s.r.o
      • Poprad, Slovakia
        • Amb. klinickey imunologie a allergologie UTaRCH
      • Trencin, Slovakia
        • Ambulancia klinickej imunologie a alergologie
      • Zilina, Slovakia
        • Medcentrum s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 51 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo control
Other: placebo
placebo control
Other Names:
  • Placebo control
ACTIVE_COMPARATOR: Grass pollen extract, twice weekly
Grass pollen extract, 9,500 BU, given twice weekly
Drug: Oralgen
allergen solution sublingually
Other Names:
  • grasspollen extract
ACTIVE_COMPARATOR: Grass pollen extract daily
Grass pollen extract, 9,500 BU, given daily
Drug: Oralgen
allergen solution sublingually
Other Names:
  • 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 Names:
  • grasspollen extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pollen Season Rhinoconjunctivitis Total Symptom Score
Time Frame: site specific pollen season
site specific pollen season

Secondary Outcome Measures

Outcome Measure
Time Frame
Rescue medication usage
Time Frame: one year
one year
Proportion of symptom-free days during the pollen season
Time Frame: one year
one year
Rhinoconjunctivitis QoL Questionnaire
Time Frame: one year
one year
Global evaluation of the efficacy by the patient
Time Frame: one year
one year
Local and systemic tolerability and other adverse events, labor
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (ESTIMATE)

January 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB0602/1
  • 2007-002477-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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