Long-term Efficacy and Safety Study With Oralgen Grass Pollen
A Randomised, DB, Plcb Controlled, Multicentre, Multinat. Phase II/III FU Study to Assess Longterm Efficacy and Safety of 3 Different Dose Regimens of Oralgen® GrassPollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
2 other identifiers
interventional
356
7 countries
39
Brief Summary
This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 15, 2009
CompletedFirst Posted
Study publicly available on registry
January 16, 2009
CompletedMay 5, 2010
May 1, 2010
1 year
January 15, 2009
May 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pollen Season Rhinoconjunctivitis Total Symptom Score
site specific pollen season
Secondary Outcomes (5)
Rescue medication usage
one year
Proportion of symptom-free days during the pollen season
one year
Rhinoconjunctivitis QoL Questionnaire
one year
Global evaluation of the efficacy by the patient
one year
Local and systemic tolerability and other adverse events, labor
one year
Study Arms (4)
Placebo control
PLACEBO COMPARATORPlacebo control
Grass pollen extract, twice weekly
ACTIVE COMPARATORGrass pollen extract, 9,500 BU, given twice weekly
Grass pollen extract daily
ACTIVE COMPARATORGrass pollen extract, 9,500 BU, given daily
Increased dose of grass pollen extract
ACTIVE COMPARATORIncreased dose of grass pollen extract, 19,000 BU, given daily
Interventions
Eligibility Criteria
You may not qualify if:
- Patients who have given their written consent to participate in this study.
- Patients who are willing to comply with the protocol and understand the information given.
- Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
- Negative urine pregnancy test if female at the end of the previous study.
- Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- Patients who were non-compliant during study AB0602.
- Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Artu Biologicalslead
Study Sites (39)
MHAT PLovdiv, ENT Clinic
Plovdiv, Bulgaria
Military Medical Academy, Clinic of ENT
Sofia, 1606, Bulgaria
Military Medical Academy
Sofia, 1606, Bulgaria
5th MHAT, ENT Clinic
Sofia, Bulgaria
Ministry of interior-central clinical database
Sofia, Bulgaria
MHAT Sveta Marina
Varna, Bulgaria
Military Medical Academy
Varna, Bulgaria
ORL Soukroma praxe
Brno, Czechia
Fakultni nemocnice Brno
Brno-Bohunice, Czechia
Nemocnice Caslav
Čáslav, Czechia
Alergologicka ordinace
Dobruška, Czechia
Alergologicka ambulance
Jablonec nad Nisou, 466 04, Czechia
Alergologicka ordinace
Kutná Hora, 284 01, Czechia
Alergologicka ambulance
Ostrava - Hrabuvka, Czechia
Ambulance plicni a alergologicka
Ostrave - Hrabuvka, Czechia
Alergologicka ambulance Okresni nemocnice Tabor
Tábor, Czechia
Berufsgen. kliniken Bergmannsheil
Bochum, Germany
Univ. klinikum Carl Gustav Carus
Dresden, Germany
MedicoKIT
Goch, Germany
Johannes-Gutenberg-Universitat Mainz
Mainz, Germany
Vital Care
München, Germany
Privataertz. inst. & Forsh. einrichtung
Wiesbaden, Germany
Svabhegyi Allami Gyermekgyogyintezet pulmonologia
Budapest, Hungary
Szent Janos Korhaz
Budapest, Hungary
Selye Janos Korhaz
Komárom, Hungary
Karolina Korhaz
Mosomagyarovar, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, Hungary
Kaunas medical University hospital
Kaunas, Lithuania
JSC Seimos gydytojas
Vilnius, Lithuania
Vilnius Central Outpatient Clinic
Vilnius, Lithuania
Vilnius university hospital, Santariskiu Clinic
Vilnius, Lithuania
Ampha Den Bosch / Regio Brabant
's-Hertogenbosch, 5233 VG, Netherlands
Ampha De Bilt
De Bilt, 3731 DN, Netherlands
Ampha
Hengelo, Netherlands
AMPHA Nijmegen
Nijmegen, 6525EC, Netherlands
Centrum imunologie a alergologie s.r.o
Bratislava, Slovakia
Amb. klinickey imunologie a allergologie UTaRCH
Poprad, Slovakia
Ambulancia klinickej imunologie a alergologie
Trenčín, Slovakia
Medcentrum s.r.o.
Žilina, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dyonne van Duren, MD, PhD
AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The Netherlands
- PRINCIPAL INVESTIGATOR
Knut Schaekel, MD, PhD
Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, Germany
- PRINCIPAL INVESTIGATOR
Iveta Kozlovska, MD, PhD
Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 15, 2009
First Posted
January 16, 2009
Study Start
August 1, 2007
Primary Completion
August 1, 2008
Study Completion
January 1, 2009
Last Updated
May 5, 2010
Record last verified: 2010-05