A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis

April 29, 2010 updated by: Artu Biologicals

A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • 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

  • Belgium
      • Brugge, Belgium, B-8000
        • AZ St Jan, Campus Sint-Jan
      • Bruxelles, Belgium, B-1200
        • Clinique Saint Luc
      • Leuven, Belgium, B-3000
        • University Hospital Leuven
      • Leuven, Belgium, B-3000
        • U.Z. St Raphael
      • Liege, Belgium, B-4000
        • CHR de la Citadelle
      • Yvoir, Belgium, B-5530
        • Clinique UCL de Mont-Godinne
  • France
      • Bordeaux, France, 33000
        • Groupe Hospitalier Pellegrin
      • Brest, France, 29200
        • Gael Taburet
      • Nantes, France, 44000
        • Francois Durand Perdriel
      • Nantes, France, 44000
        • Francois Wessel
      • Nantes, France, 44000
        • Michel Anton
      • Quimper, France, 29000
        • Françoise Sanquer
      • Reze, France, 44400
        • Bruno Lebeaupin
      • Strasbourg cedex, France, 67091
        • CHRU de Strasbourg
      • Toulon, France, 83000
        • Mathieu Larrousse
  • Germany
      • Berlin, Germany, 10117
        • Allergie-Centrum-Charité
      • Bochum, Germany
        • Berufsgen. kliniken Bergmannsheil
      • Bonn, Germany, 53105
        • Universitätsklinik Bonn
      • Dresden, Germany, 01307
        • Uniklinikum Carl Gustav Carus
      • Frankfurt am Main, Germany, 60590
        • Uniklinikum Frankfurt
      • Goch, Germany
        • MedicoKIT
      • Halle, Germany, 06112
        • Universitatsklinikum Halle (Saale)
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein
      • München, Germany, 80337
        • Klinikum der Universität München
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
  • Netherlands
      • Alphen aan de Rijn, Netherlands, 2402 WC
        • Rijnland Ziekenhuis, Location Alphen - Poli KNO
      • Assen, Netherlands
        • Wilhelmina Ziekenhuis
      • De Bilt, Netherlands, 3731 DN
        • Ampha De Bilt
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Nijmegen, Netherlands, 6525EC
        • AMPHA Nijmegen
      • Tilburg, Netherlands, 5022 GC
        • Sint Elisabeth Ziekenhuis
  • Poland
      • Bialystok, Poland, 15-084
        • Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny
      • Bienkowka, Poland, 34-212
        • SP-ZOZ Osrodek Zdrowia w Bienkowce
      • Bydgoszcz, Poland, 85-168
        • SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela
      • Katowice, Poland, 40-084
        • Slaskie Centrum Osteoporozy
      • Lodz, Poland, 90-153
        • SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1
      • Lodz, Poland, 90-553
        • NZOZ Centrum Alergologii Prof. Buczylko
      • Lublin, Poland, 20-718
        • SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
      • Poznan, Poland, 60-214
        • Centrum Alergologii Teresa Hofman
      • Wroclaw, Poland, 54-239
        • NZOZ Lekarze Specjalisci
      • Zabrze, Poland, 41-800
        • Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
      • Zabrze, Poland, 41-803
        • Samodzielny Publiczny Szpital Kliniczny nr 3
  • United Kingdom
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
        • Layton Medical Centre
      • Brighton, United Kingdom, BN2 3 EW
        • Brighton General Hospital
      • Chippenham, United Kingdom, SN14 6GT
        • Hathaway Medical Centre
      • Crownhill, Plymouth, United Kingdom, PL5 3JB
        • House Surgery
      • London, United Kingdom, W2 1NY
        • St. Mary's Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, WC1X 8DA
        • Royal National Throat, Nose & Ear Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • QMC Notthingham, Nottingham University Hospitals NHS Trust
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • St Stephen, St Austell, United Kingdom, PL26 7RL
        • Brannel Surgery
      • Warminster, United Kingdom, BA12 9AA
        • Avenue Surgery
    • Cornwal
      • Fowey, Cornwal, United Kingdom, Pl23 1DT
        • Fowey River Practice
    • Cornwall
      • Penzance, Cornwall, United Kingdom, TR18 4JH
        • The Alverton Practice
      • Saltash, Cornwall, United Kingdom, PL12 6DL
        • Saltash Health Centre
      • St Just, Cornwall, United Kingdom, TR19 7HX
        • Cape Cornwall Surgery
    • Past Sussex
      • Bexhill-on-Sea, Past Sussex, United Kingdom, TN40 1JJ
        • Sea Road Surgery
    • Warwickshire
      • Atherstone, Warwickshire, United Kingdom, CV9 1EU
        • Atherstone Surgery
    • Wiltshire
      • Corsham, Wiltshire, United Kingdom, SN13 9DL
        • The Porch Surgery

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female
  • grass pollen related rhinoconjunctivitis symptoms for at least the last 2 pollen seasons
  • positive skin prick test RRTSS greater or equal to 12 during the 2008 season
  • signed informed consent

Exclusion Criteria:

  • positive skin prick test for other environmental allergens and suffering from serious allergic symptoms
  • clinical history of significant symptomatic allergic rhinitis due to tree/weed pollen which potentially overlap the grass pollen season
  • clinical history of symptomatic perennial allergic rhinitis caused by an allergen to which the patient is regularly exposed
  • lacking of good health
  • abnormal spirometry
  • lower respiratory tract infection
  • asthma requiring treatment other than beta-2 agonists
  • oral steroids within 12 weeks before screening
  • regular contraindications for use of immunotherapy

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Grass pollen extract
Subjects will receive 19.000 BU grass pollen extract daily sublingually
Drug: Oralgen
19.000 BU daily
Other Names:
  • Grass pollen extract
Placebo Comparator: Placebo control
Subjects will receive matching placebo control daily sublingually
Other: placebo control
placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between active and placebo-group based on combined RTSS and RMS score
Time Frame: third season
third season

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference between active and placebo based on RTSS score
Time Frame: third season
third season

Collaborators and Investigators

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

Sponsor

Artu Biologicals

Investigators

  • Study Director: Folkert Roossien, Artu-Biologicals Europe B.V.

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

December 1, 2008

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2010

Last Update Submitted That Met QC Criteria

April 29, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB0801

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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