Clinical trial NCT00812799: A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Allergic Rhinoconjunctivitis
Keywords: randomised
double-blind
placebo-controlled
efficacy and safety
Oralgen® Grass Pollen
allergic rhinoconjunctivitis
allergy
rhinoconjunctivitis
immunotherapy
grass pollen extract
Lead sponsor: Artu Biologicals
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between active and placebo-group based on combined RTSS and RMS score
timeFrame: third season
Secondary outcomes:
measure: Difference between active and placebo based on RTSS score
timeFrame: third season
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ St Jan, Campus Sint-Jan
city: Bruxelles
country: Belgium
facility: Clinique Saint Luc
city: Leuven
country: Belgium
facility: U.Z. St Raphael
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Yvoir
country: Belgium
facility: Clinique UCL de Mont-Godinne
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Brest
country: France
facility: Gael Taburet
city: Nantes
country: France
facility: Francois Durand Perdriel
city: Nantes
country: France
facility: Francois Wessel
city: Nantes
country: France
facility: Michel Anton
city: Quimper
country: France
facility: Françoise Sanquer
city: Reze
country: France
facility: Bruno Lebeaupin
city: Strasbourg cedex
country: France
facility: CHRU de Strasbourg
city: Toulon
country: France
facility: Mathieu Larrousse
city: Berlin
country: Germany
facility: Allergie-Centrum-Charité
city: Bochum
country: Germany
facility: Berufsgen. kliniken Bergmannsheil
city: Bonn
country: Germany
facility: Universitätsklinik Bonn
city: Dresden
country: Germany
facility: Uniklinikum Carl Gustav Carus
city: Frankfurt am Main
country: Germany
facility: Uniklinikum Frankfurt
city: Goch
country: Germany
facility: MedicoKIT
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: München
country: Germany
facility: Klinikum der Universität München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Alphen aan de Rijn
country: Netherlands
facility: Rijnland Ziekenhuis, Location Alphen - Poli KNO
city: Assen
country: Netherlands
facility: Wilhelmina ziekenhuis
city: De Bilt
country: Netherlands
facility: Ampha De Bilt
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: AMPHA Nijmegen
city: Tilburg
country: Netherlands
facility: Sint Elisabeth Ziekenhuis
city: Bialystok
country: Poland
facility: Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny
city: Bienkowka
country: Poland
facility: SP-ZOZ Osrodek Zdrowia w Bienkowce
city: Bydgoszcz
country: Poland
facility: SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela
city: Katowice
country: Poland
facility: Slaskie Centrum Osteoporozy
city: Lodz
country: Poland
facility: SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1
city: Lodz
country: Poland
facility: NZOZ Centrum Alergologii Prof. Buczylko
city: Lublin
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
city: Poznan
country: Poland
facility: Centrum Alergologii Teresa Hofman
city: Wroclaw
country: Poland
facility: NZOZ Lekarze Specjalisci
city: Zabrze
country: Poland
facility: Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 3
city: Penzance
country: United Kingdom
facility: The Alverton Practice
state: Cornwall
city: Saltash
country: United Kingdom
facility: Saltash Health Centre
state: Cornwall
city: St Just
country: United Kingdom
facility: Cape Cornwall Surgery
state: Cornwall
city: Fowey
country: United Kingdom
facility: Fowey River Practice
state: Cornwal
city: Bexhill-on-Sea
country: United Kingdom
facility: Sea Road Surgery
state: Past Sussex
city: Atherstone
country: United Kingdom
facility: Atherstone Surgery
state: Warwickshire
city: Corsham
country: United Kingdom
facility: The Porch Surgery
state: Wiltshire
city: Blackpool, Lancashire
country: United Kingdom
facility: Layton Medical Centre
city: Brighton
country: United Kingdom
facility: Brighton General Hospital
city: Chippenham
country: United Kingdom
facility: Hathaway Medical Centre
city: Crownhill, Plymouth
country: United Kingdom
facility: House Surgery
city: London
country: United Kingdom
facility: Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: London
country: United Kingdom
facility: Royal National Throat, Nose & Ear Hospital
city: Nottingham
country: United Kingdom
facility: QMC Notthingham, Nottingham University Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: St Stephen, St Austell
country: United Kingdom
facility: Brannel Surgery
city: Warminster
country: United Kingdom
facility: Avenue Surgery
Study officials:
affiliation: Artu-Biologicals Europe B.V.
name: Folkert Roossien
role: STUDY_DIRECTOR
References: