A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis
- Registration Number
- NCT00812799
- Lead Sponsor
- Artu Biologicals
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 374
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Grass pollen extract Oralgen Subjects will receive 19.000 BU grass pollen extract daily sublingually Placebo control placebo control Subjects will receive matching placebo control daily sublingually
- Primary Outcome Measures
Name Time Method Difference between active and placebo-group based on combined RTSS and RMS score third season
- Secondary Outcome Measures
Name Time Method Difference between active and placebo based on RTSS score third season
Trial Locations
- Locations (60)
Slaskie Centrum Osteoporozy
π΅π±Katowice, Poland
Saltash Health Centre
π¬π§Saltash, Cornwall, United Kingdom
The Porch Surgery
π¬π§Corsham, Wiltshire, United Kingdom
Hathaway Medical Centre
π¬π§Chippenham, United Kingdom
The Alverton Practice
π¬π§Penzance, Cornwall, United Kingdom
Layton Medical Centre
π¬π§Blackpool, Lancashire, United Kingdom
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
π¬π§London, United Kingdom
Royal National Throat, Nose & Ear Hospital
π¬π§London, United Kingdom
Fowey River Practice
π¬π§Fowey, Cornwal, United Kingdom
NZOZ Centrum Alergologii Prof. Buczylko
π΅π±Lodz, Poland
Centrum Alergologii Teresa Hofman
π΅π±Poznan, Poland
Samodzielny Publiczny Szpital Kliniczny nr 3
π΅π±Zabrze, Poland
Brighton General Hospital
π¬π§Brighton, United Kingdom
House Surgery
π¬π§Crownhill, Plymouth, United Kingdom
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1
π΅π±Lodz, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana KardynaΕa WyszyΕskiego
π΅π±Lublin, Poland
NZOZ Lekarze Specjalisci
π΅π±Wroclaw, Poland
Sea Road Surgery
π¬π§Bexhill-on-Sea, Past Sussex, United Kingdom
Brannel Surgery
π¬π§St Stephen, St Austell, United Kingdom
QMC Notthingham, Nottingham University Hospitals NHS Trust
π¬π§Nottingham, United Kingdom
St. Mary's Hospital
π¬π§London, United Kingdom
Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
π΅π±Zabrze, Poland
Atherstone Surgery
π¬π§Atherstone, Warwickshire, United Kingdom
Cape Cornwall Surgery
π¬π§St Just, Cornwall, United Kingdom
Northern General Hospital
π¬π§Sheffield, United Kingdom
Avenue Surgery
π¬π§Warminster, United Kingdom
AZ St Jan, Campus Sint-Jan
π§πͺBrugge, Belgium
Clinique Saint Luc
π§πͺBruxelles, Belgium
U.Z. St Raphael
π§πͺLeuven, Belgium
CHR de la Citadelle
π§πͺLiege, Belgium
Clinique UCL de Mont-Godinne
π§πͺYvoir, Belgium
Gael Taburet
π«π·Brest, France
University Hospital Leuven
π§πͺLeuven, Belgium
Groupe Hospitalier Pellegrin
π«π·Bordeaux, France
Francois Wessel
π«π·Nantes, France
Francois Durand Perdriel
π«π·Nantes, France
Michel Anton
π«π·Nantes, France
Bruno Lebeaupin
π«π·Reze, France
UniversitΓ€tsklinik Bonn
π©πͺBonn, Germany
Allergie-Centrum-CharitΓ©
π©πͺBerlin, Germany
Uniklinikum Carl Gustav Carus
π©πͺDresden, Germany
CHRU de Strasbourg
π«π·Strasbourg cedex, France
Mathieu Larrousse
π«π·Toulon, France
Berufsgen. kliniken Bergmannsheil
π©πͺBochum, Germany
Françoise Sanquer
π«π·Quimper, France
Uniklinikum Frankfurt
π©πͺFrankfurt am Main, Germany
UniversitΓ€tsklinikum Schleswig-Holstein
π©πͺLΓΌbeck, Germany
MedicoKIT
π©πͺGoch, Germany
UniversitΓ€tsklinikum Halle (Saale)
π©πͺHalle, Germany
Wilhelmina ziekenhuis
π³π±Assen, Netherlands
Ampha De Bilt
π³π±De Bilt, Netherlands
Klinikum der UniversitΓ€t MΓΌnchen
π©πͺMΓΌnchen, Germany
Rijnland Ziekenhuis, Location Alphen - Poli KNO
π³π±Alphen aan de Rijn, Netherlands
UniversitΓ€tsklinikum MΓΌnster
π©πͺMΓΌnster, Germany
SP-ZOZ Osrodek Zdrowia w Bienkowce
π΅π±Bienkowka, Poland
Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny
π΅π±Bialystok, Poland
Catharina Ziekenhuis
π³π±Eindhoven, Netherlands
AMPHA Nijmegen
π³π±Nijmegen, Netherlands
Sint Elisabeth Ziekenhuis
π³π±Tilburg, Netherlands
SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela
π΅π±Bydgoszcz, Poland