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

Allergic Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00812799
• Other study ID #: AB0801
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 19, 2008
• Last updated: April 29, 2010
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2010
• Source: Artu Biologicals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencyBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Institutional Ethical CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 374
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Oralgen
19.000 BU daily

Other:
• placebo control
placebo control

Locations

Country	Name	City	State
Belgium	AZ St Jan, Campus Sint-Jan	Brugge
Belgium	Clinique Saint Luc	Bruxelles
Belgium	U.Z. St Raphael	Leuven
Belgium	University Hospital Leuven	Leuven
Belgium	CHR de la Citadelle	Liege
Belgium	Clinique UCL de Mont-Godinne	Yvoir
France	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	Reze
France	CHRU de Strasbourg	Strasbourg cedex
France	Mathieu Larrousse	Toulon
Germany	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
Netherlands	Rijnland Ziekenhuis, Location Alphen - Poli KNO	Alphen aan de Rijn
Netherlands	Wilhelmina ziekenhuis	Assen
Netherlands	Ampha De Bilt	De Bilt
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	AMPHA Nijmegen	Nijmegen
Netherlands	Sint Elisabeth Ziekenhuis	Tilburg
Poland	Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny	Bialystok
Poland	SP-ZOZ Osrodek Zdrowia w Bienkowce	Bienkowka
Poland	SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela	Bydgoszcz
Poland	Slaskie Centrum Osteoporozy	Katowice
Poland	NZOZ Centrum Alergologii Prof. Buczylko	Lodz
Poland	SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1	Lodz
Poland	SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego	Lublin
Poland	Centrum Alergologii Teresa Hofman	Poznan
Poland	NZOZ Lekarze Specjalisci	Wroclaw
Poland	Samodzielny Publiczny Szpital Kliniczny nr 3	Zabrze
Poland	Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach	Zabrze
United Kingdom	Atherstone Surgery	Atherstone	Warwickshire
United Kingdom	Sea Road Surgery	Bexhill-on-Sea	Past Sussex
United Kingdom	Layton Medical Centre	Blackpool, Lancashire
United Kingdom	Brighton General Hospital	Brighton
United Kingdom	Hathaway Medical Centre	Chippenham
United Kingdom	The Porch Surgery	Corsham	Wiltshire
United Kingdom	House Surgery	Crownhill, Plymouth
United Kingdom	Fowey River Practice	Fowey	Cornwal
United Kingdom	Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Royal National Throat, Nose & Ear Hospital	London
United Kingdom	St. Mary's Hospital	London
United Kingdom	QMC Notthingham, Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	The Alverton Practice	Penzance	Cornwall
United Kingdom	Saltash Health Centre	Saltash	Cornwall
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	Cape Cornwall Surgery	St Just	Cornwall
United Kingdom	Brannel Surgery	St Stephen, St Austell
United Kingdom	Avenue Surgery	Warminster

Sponsors (1)

Lead Sponsor	Collaborator
Artu Biologicals

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between active and placebo-group based on combined RTSS and RMS score		third season	No
Secondary	Difference between active and placebo based on RTSS score		third season	No