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

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oralgen
placebo control
Sponsored by
Artu Biologicals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, allergy, rhinoconjunctivitis, immunotherapy, grass pollen extract

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ St Jan, Campus Sint-Jan
  • Clinique Saint Luc
  • U.Z. St Raphael
  • University Hospital Leuven
  • CHR de la Citadelle
  • Clinique UCL de Mont-Godinne
  • Groupe Hospitalier Pellegrin
  • Gael Taburet
  • Francois Durand Perdriel
  • Francois Wessel
  • Michel Anton
  • Françoise Sanquer
  • Bruno Lebeaupin
  • CHRU de Strasbourg
  • Mathieu Larrousse
  • Allergie-Centrum-Charité
  • Berufsgen. kliniken Bergmannsheil
  • Universitätsklinik Bonn
  • Uniklinikum Carl Gustav Carus
  • Uniklinikum Frankfurt
  • MedicoKIT
  • Universitätsklinikum Halle (Saale)
  • Universitätsklinikum Schleswig-Holstein
  • Klinikum der Universität München
  • Universitätsklinikum Münster
  • Rijnland Ziekenhuis, Location Alphen - Poli KNO
  • Wilhelmina ziekenhuis
  • Ampha De Bilt
  • Catharina Ziekenhuis
  • AMPHA Nijmegen
  • Sint Elisabeth Ziekenhuis
  • Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny
  • SP-ZOZ Osrodek Zdrowia w Bienkowce
  • SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela
  • Slaskie Centrum Osteoporozy
  • SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1
  • NZOZ Centrum Alergologii Prof. Buczylko
  • SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
  • Centrum Alergologii Teresa Hofman
  • NZOZ Lekarze Specjalisci
  • Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
  • Samodzielny Publiczny Szpital Kliniczny nr 3
  • The Alverton Practice
  • Saltash Health Centre
  • Cape Cornwall Surgery
  • Fowey River Practice
  • Sea Road Surgery
  • Atherstone Surgery
  • The Porch Surgery
  • Layton Medical Centre
  • Brighton General Hospital
  • Hathaway Medical Centre
  • House Surgery
  • Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
  • St. Mary's Hospital
  • Royal National Throat, Nose & Ear Hospital
  • QMC Notthingham, Nottingham University Hospitals NHS Trust
  • Northern General Hospital
  • Brannel Surgery
  • Avenue Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Grass pollen extract

Placebo control

Arm Description

Subjects will receive 19.000 BU grass pollen extract daily sublingually

Subjects will receive matching placebo control daily sublingually

Outcomes

Primary Outcome Measures

Difference between active and placebo-group based on combined RTSS and RMS score

Secondary Outcome Measures

Difference between active and placebo based on RTSS score

Full Information

First Posted
December 19, 2008
Last Updated
April 29, 2010
Sponsor
Artu Biologicals
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1. Study Identification

Unique Protocol Identification Number
NCT00812799
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Artu Biologicals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
Keywords
randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, allergy, rhinoconjunctivitis, immunotherapy, grass pollen extract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grass pollen extract
Arm Type
Active Comparator
Arm Description
Subjects will receive 19.000 BU grass pollen extract daily sublingually
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
Subjects will receive matching placebo control daily sublingually
Intervention Type
Drug
Intervention Name(s)
Oralgen
Other Intervention Name(s)
Grass pollen extract
Intervention Description
19.000 BU daily
Intervention Type
Other
Intervention Name(s)
placebo control
Intervention Description
placebo control
Primary Outcome Measure Information:
Title
Difference between active and placebo-group based on combined RTSS and RMS score
Time Frame
third season
Secondary Outcome Measure Information:
Title
Difference between active and placebo based on RTSS score
Time Frame
third season

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Folkert Roossien
Organizational Affiliation
Artu-Biologicals Europe B.V.
Official's Role
Study Director
Facility Information:
Facility Name
AZ St Jan, Campus Sint-Jan
City
Brugge
ZIP/Postal Code
B-8000
Country
Belgium
Facility Name
Clinique Saint Luc
City
Bruxelles
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
U.Z. St Raphael
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Clinique UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
Groupe Hospitalier Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Gael Taburet
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Francois Durand Perdriel
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Francois Wessel
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Michel Anton
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Françoise Sanquer
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Bruno Lebeaupin
City
Reze
ZIP/Postal Code
44400
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Mathieu Larrousse
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Allergie-Centrum-Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Berufsgen. kliniken Bergmannsheil
City
Bochum
Country
Germany
Facility Name
Universitätsklinik Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Uniklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Uniklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
MedicoKIT
City
Goch
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06112
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum der Universität München
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Rijnland Ziekenhuis, Location Alphen - Poli KNO
City
Alphen aan de Rijn
ZIP/Postal Code
2402 WC
Country
Netherlands
Facility Name
Wilhelmina ziekenhuis
City
Assen
Country
Netherlands
Facility Name
Ampha De Bilt
City
De Bilt
ZIP/Postal Code
3731 DN
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
AMPHA Nijmegen
City
Nijmegen
ZIP/Postal Code
6525EC
Country
Netherlands
Facility Name
Sint Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny
City
Bialystok
ZIP/Postal Code
15-084
Country
Poland
Facility Name
SP-ZOZ Osrodek Zdrowia w Bienkowce
City
Bienkowka
ZIP/Postal Code
34-212
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Slaskie Centrum Osteoporozy
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
NZOZ Centrum Alergologii Prof. Buczylko
City
Lodz
ZIP/Postal Code
90-553
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Centrum Alergologii Teresa Hofman
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
NZOZ Lekarze Specjalisci
City
Wroclaw
ZIP/Postal Code
54-239
Country
Poland
Facility Name
Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 3
City
Zabrze
ZIP/Postal Code
41-803
Country
Poland
Facility Name
The Alverton Practice
City
Penzance
State/Province
Cornwall
ZIP/Postal Code
TR18 4JH
Country
United Kingdom
Facility Name
Saltash Health Centre
City
Saltash
State/Province
Cornwall
ZIP/Postal Code
PL12 6DL
Country
United Kingdom
Facility Name
Cape Cornwall Surgery
City
St Just
State/Province
Cornwall
ZIP/Postal Code
TR19 7HX
Country
United Kingdom
Facility Name
Fowey River Practice
City
Fowey
State/Province
Cornwal
ZIP/Postal Code
Pl23 1DT
Country
United Kingdom
Facility Name
Sea Road Surgery
City
Bexhill-on-Sea
State/Province
Past Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Atherstone Surgery
City
Atherstone
State/Province
Warwickshire
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
The Porch Surgery
City
Corsham
State/Province
Wiltshire
ZIP/Postal Code
SN13 9DL
Country
United Kingdom
Facility Name
Layton Medical Centre
City
Blackpool, Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Brighton General Hospital
City
Brighton
ZIP/Postal Code
BN2 3 EW
Country
United Kingdom
Facility Name
Hathaway Medical Centre
City
Chippenham
ZIP/Postal Code
SN14 6GT
Country
United Kingdom
Facility Name
House Surgery
City
Crownhill, Plymouth
ZIP/Postal Code
PL5 3JB
Country
United Kingdom
Facility Name
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Royal National Throat, Nose & Ear Hospital
City
London
ZIP/Postal Code
WC1X 8DA
Country
United Kingdom
Facility Name
QMC Notthingham, Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Brannel Surgery
City
St Stephen, St Austell
ZIP/Postal Code
PL26 7RL
Country
United Kingdom
Facility Name
Avenue Surgery
City
Warminster
ZIP/Postal Code
BA12 9AA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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