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

NCT00812799 | Unknown Phase 3

• 1 other identifier: AB0801
• Study Type: interventional
• Target: 374
• Locations: 6 countries
• Sites: 60

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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

randomised; double-blind; placebo-controlled; efficacy and safety; Oralgen® Grass Pollen; allergic rhinoconjunctivitis; allergy; rhinoconjunctivitis; immunotherapy; grass pollen extract

Outcome Measures

Primary Outcomes (1)

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

  third season

Secondary Outcomes (1)

• Difference between active and placebo based on RTSS score

  third season

Study Arms (2)

Grass pollen extract

ACTIVE COMPARATOR

Subjects will receive 19.000 BU grass pollen extract daily sublingually

Drug: Oralgen

Placebo control

PLACEBO COMPARATOR

Subjects will receive matching placebo control daily sublingually

Other: placebo control

Interventions

Oralgen DRUG

19.000 BU daily

Also known as: Grass pollen extract

Grass pollen extract

placebo control OTHER

placebo control

Placebo control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artu Biologicals: lead

Study Sites (60)

AZ St Jan, Campus Sint-Jan

Bruges, B-8000, Belgium

Location

Clinique Saint Luc

Brussels, B-1200, Belgium

Location

U.Z. St Raphael

Leuven, B-3000, Belgium

Location

University Hospital Leuven

Leuven, B-3000, Belgium

Location

CHR de la Citadelle

Liège, B-4000, Belgium

Location

Clinique UCL de Mont-Godinne

Yvoir, B-5530, Belgium

Location

Groupe Hospitalier Pellegrin

Bordeaux, 33000, France

Location

Gael Taburet

Brest, 29200, France

Location

Francois Durand Perdriel

Nantes, 44000, France

Location

Francois Wessel

Nantes, 44000, France

Location

Michel Anton

Nantes, 44000, France

Location

Françoise Sanquer

Quimper, 29000, France

Location

Bruno Lebeaupin

Rezé, 44400, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

Mathieu Larrousse

Toulon, 83000, France

Location

Allergie-Centrum-Charité

Berlin, 10117, Germany

Location

Berufsgen. kliniken Bergmannsheil

Bochum, Germany

Location

Universitätsklinik Bonn

Bonn, 53105, Germany

Location

Uniklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Uniklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

MedicoKIT

Goch, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06112, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Klinikum der Universität München

München, 80337, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Rijnland Ziekenhuis, Location Alphen - Poli KNO

Alphen aan den Rijn, 2402 WC, Netherlands

Location

Wilhelmina ziekenhuis

Assen, Netherlands

Location

Ampha De Bilt

De Bilt, 3731 DN, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

AMPHA Nijmegen

Nijmegen, 6525EC, Netherlands

Location

Sint Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny

Bialystok, 15-084, Poland

Location

SP-ZOZ Osrodek Zdrowia w Bienkowce

Bieńkówka, 34-212, Poland

Location

SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela

Bydgoszcz, 85-168, Poland

Location

Slaskie Centrum Osteoporozy

Katowice, 40-084, Poland

Location

SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1

Lodz, 90-153, Poland

Location

NZOZ Centrum Alergologii Prof. Buczylko

Lodz, 90-553, Poland

Location

SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

Lublin, 20-718, Poland

Location

Centrum Alergologii Teresa Hofman

Poznan, 60-214, Poland

Location

NZOZ Lekarze Specjalisci

Wroclaw, 54-239, Poland

Location

Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

Zabrze, 41-800, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 3

Zabrze, 41-803, Poland

Location

The Alverton Practice

Penzance, Cornwall, TR18 4JH, United Kingdom

Location

Saltash Health Centre

Saltash, Cornwall, PL12 6DL, United Kingdom

Location

Cape Cornwall Surgery

St Just, Cornwall, TR19 7HX, United Kingdom

Location

Fowey River Practice

Fowey, Cornwal, Pl23 1DT, United Kingdom

Location

Sea Road Surgery

Bexhill-on-Sea, Past Sussex, TN40 1JJ, United Kingdom

Location

Atherstone Surgery

Atherstone, Warwickshire, CV9 1EU, United Kingdom

Location

The Porch Surgery

Corsham, Wiltshire, SN13 9DL, United Kingdom

Location

Layton Medical Centre

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

Brighton General Hospital

Brighton, BN2 3 EW, United Kingdom

Location

Hathaway Medical Centre

Chippenham, SN14 6GT, United Kingdom

Location

House Surgery

Crownhill, Plymouth, PL5 3JB, United Kingdom

Location

Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Royal National Throat, Nose & Ear Hospital

London, WC1X 8DA, United Kingdom

Location

QMC Notthingham, Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Brannel Surgery

Saint Stephen, Saint Austell, PL26 7RL, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

Avenue Surgery

Warminster, BA12 9AA, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

grass pollen extract, alum-adsorbed

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Folkert Roossien

  Artu-Biologicals Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 30, 2010

Record last verified: 2010-04

Locations

BE (6); NL (6); PL (11); FR (9); GB (18); DE (10)