A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis
NCT ID: NCT00812799
Last Updated: 2010-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
374 participants
INTERVENTIONAL
2008-12-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Grass pollen extract
Subjects will receive 19.000 BU grass pollen extract daily sublingually
Oralgen
19.000 BU daily
Placebo control
Subjects will receive matching placebo control daily sublingually
placebo control
placebo control
Interventions
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Oralgen
19.000 BU daily
placebo control
placebo control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Artu Biologicals
INDUSTRY
Responsible Party
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Artu Biologicals Europe B.V.
Principal Investigators
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Folkert Roossien
Role: STUDY_DIRECTOR
Artu-Biologicals Europe B.V.
Locations
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AZ St Jan, Campus Sint-Jan
Bruges, , Belgium
Clinique Saint Luc
Brussels, , Belgium
U.Z. St Raphael
Leuven, , Belgium
University Hospital Leuven
Leuven, , Belgium
CHR de la Citadelle
Liège, , Belgium
Clinique UCL de Mont-Godinne
Yvoir, , Belgium
Groupe Hospitalier Pellegrin
Bordeaux, , France
Gael Taburet
Brest, , France
Francois Durand Perdriel
Nantes, , France
Francois Wessel
Nantes, , France
Michel Anton
Nantes, , France
Françoise Sanquer
Quimper, , France
Bruno Lebeaupin
Rezé, , France
CHRU de Strasbourg
Strasbourg, , France
Mathieu Larrousse
Toulon, , France
Allergie-Centrum-Charité
Berlin, , Germany
Berufsgen. kliniken Bergmannsheil
Bochum, , Germany
Universitätsklinik Bonn
Bonn, , Germany
Uniklinikum Carl Gustav Carus
Dresden, , Germany
Uniklinikum Frankfurt
Frankfurt am Main, , Germany
MedicoKIT
Goch, , Germany
Universitätsklinikum Halle (Saale)
Halle, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Klinikum der Universität München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Rijnland Ziekenhuis, Location Alphen - Poli KNO
Alphen aan den Rijn, , Netherlands
Wilhelmina ziekenhuis
Assen, , Netherlands
Ampha De Bilt
De Bilt, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
AMPHA Nijmegen
Nijmegen, , Netherlands
Sint Elisabeth Ziekenhuis
Tilburg, , Netherlands
Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny
Bialystok, , Poland
SP-ZOZ Osrodek Zdrowia w Bienkowce
Bieńkówka, , Poland
SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela
Bydgoszcz, , Poland
Slaskie Centrum Osteoporozy
Katowice, , Poland
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1
Lodz, , Poland
NZOZ Centrum Alergologii Prof. Buczylko
Lodz, , Poland
SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
Lublin, , Poland
Centrum Alergologii Teresa Hofman
Poznan, , Poland
NZOZ Lekarze Specjalisci
Wroclaw, , Poland
Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
Zabrze, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 3
Zabrze, , Poland
The Alverton Practice
Penzance, Cornwall, United Kingdom
Saltash Health Centre
Saltash, Cornwall, United Kingdom
Cape Cornwall Surgery
St Just, Cornwall, United Kingdom
Fowey River Practice
Fowey, Cornwal, United Kingdom
Sea Road Surgery
Bexhill-on-Sea, Past Sussex, United Kingdom
Atherstone Surgery
Atherstone, Warwickshire, United Kingdom
The Porch Surgery
Corsham, Wiltshire, United Kingdom
Layton Medical Centre
Blackpool, Lancashire, , United Kingdom
Brighton General Hospital
Brighton, , United Kingdom
Hathaway Medical Centre
Chippenham, , United Kingdom
House Surgery
Crownhill, Plymouth, , United Kingdom
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Royal National Throat, Nose & Ear Hospital
London, , United Kingdom
QMC Notthingham, Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Brannel Surgery
Saint Stephen, Saint Austell, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Avenue Surgery
Warminster, , United Kingdom
Countries
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Other Identifiers
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AB0801
Identifier Type: -
Identifier Source: org_study_id