Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

May 4, 2010 updated by: Artu Biologicals

A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.

Study Type

Interventional

Enrollment (Actual)

605

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria
        • MHAT PLovdiv, ENT Clinic
      • Sofia, Bulgaria
        • Military Medical Academy
      • Sofia, Bulgaria
        • 5th MHAT, ENT Clinic
      • Sofia, Bulgaria
        • Ministry of interior-central clinical database
      • Varna, Bulgaria
        • MHAT Sveta Marina
      • Varna, Bulgaria
        • Military Medical Academy
  • Czech Republic
      • Brno, Czech Republic
        • ORL Soukroma praxe
      • Brno-Bohunice, Czech Republic
        • Fakultni nemocnice Brno
      • Caslav, Czech Republic
        • Nemocnice Caslav
      • Dobruska, Czech Republic
        • Alergologicka ordinace
      • Jablonec nad Nisou, Czech Republic
        • Alergologicka ambulance
      • Kutna Hora, Czech Republic
        • Alergologicka ordinace
      • Ostrava - Hrabuvka, Czech Republic
        • Alergologicka ambulance
      • Ostrave - Hrabuvka, Czech Republic
        • Ambulance plicni a alergologicka
      • Tabor, Czech Republic
        • Alergologicka ambulance Okresni nemocnice Tabor
  • Germany
      • Bochum, Germany
        • Berufsgen. kliniken Bergmannsheil
      • Dresden, Germany
        • Univ. klinikum Carl Gustav Carus
      • Goch, Germany
        • MedicoKIT
      • Mainz, Germany
        • Johannes-Gutenberg-Universität Mainz
      • Muenchen, Germany
        • Vital Care
      • Wiesbaden, Germany
        • Privataertz. inst. & Forsh. einrichtung
  • Hungary
      • Budapest, Hungary
        • Svabhegyi Allami Gyermekgyogyintezet pulmonologia
      • Budapest, Hungary
        • Szent János Kórház
      • Komarom, Hungary
        • Selye János Kórház
      • Mosomagyarovar, Hungary
        • Karolina Korhaz
      • Torokbalint, Hungary
        • Tudogyogyintezet Torokbalint
  • Lithuania
      • Kaunas, Lithuania
        • Kaunas Medical University Hospital
      • Klaipeda, Lithuania
        • Klaipeda Regional Hospital
      • Vilnius, Lithuania
        • JSC Seimos gydytojas
      • Vilnius, Lithuania
        • Vilnius Central Outpatient Clinic
      • Vilnius, Lithuania
        • Vilnius university hospital, Santariskiu Clinic
  • Netherlands
      • De Bilt, Netherlands
        • Ampha
      • Den Bosch, Netherlands
        • Ampha
      • Hengelo, Netherlands
        • Ampha
      • Nijmegen, Netherlands
        • Menox
  • Slovakia
      • Bratislava, Slovakia
        • Centrum imunologie a alergologie s.r.o
      • Nove Zamky, Slovakia
        • FNsP Nove Zamky, ambulancia TaRCh
      • Poprad, Slovakia
        • Amb. klinickey imunologie a allergologie UTaRCH
      • Trencin, Slovakia
        • Ambulancia klinickej imunologie a alergologie
      • Zilina, Slovakia
        • Medcentrum s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female aged 18-50
  • patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
  • Positive skin prick test and IgE value of at least Class 2+
  • RTSS of greater or equal to 14 during pollen season prior tot the start of the study
  • Patients must be in general good health
  • Patients with normal spirometry
  • Informed consent given and willing to comply with the protocol
  • Female patients are eligible if they use an accepted contraceptive method
  • Negative urine pregnancy test if female

Exclusion Criteria:

  • Pregnancy, breast feeding
  • Asthma requiring treatment other than beta-2 inhaled agonists
  • patients who have taken oral steroids within 12 weeks before screening visit
  • patients who have received desensitisation treatment for grass pollen
  • treatment by immunotherapy with any other allergen within the previous 5 years
  • patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
  • patients at risk of non-compliance
  • participation in any other clinical study within the previous 3 months
  • patients with a past or current disease, which may affect participation in or outcome of this study.
  • patients treated with beta-blockers or under continuous corticotherapy
  • allergic sensitivity to epithelial allergens the patients is exposed to
  • positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
  • intention to subject the patient to surgery of the nasal cavity during current study
  • Usual contraindications of immunotherapy
  • a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: grass pollen extract twice weekly
Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given.
Drug: Oralgen
Patients will receive drops of grass pollen immunotherapy sublingually
Other Names:
  • grass pollen extract
Active Comparator: Grass pollen extract, daily
Grass pollen immunotherapy, 9,500 BU, given daily
Drug: Oralgen
Patients will receive drops of grass pollen immunotherapy sublingually
Other Names:
  • grass pollen extract
Active Comparator: Increased dose of grass pollen extract
Increased dose of grass pollen immunotherapy, 19,000 BU, given daily
Drug: Oralgen
Patients will receive drops of grass pollen immunotherapy sublingually
Other Names:
  • grass pollen extract
Placebo Comparator: Placebo control
Patients randomized to placebo will receive placebo daily.
Drug: grass pollen extract
Patients will receive matching placebo sublingually
Other Names:
  • Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artu Biologicals

Investigators

  • Study Director: Folkert R Roossien, Artu-Biologicals Europe B.V., the Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 3, 2007

First Submitted That Met QC Criteria

December 3, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

May 5, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB0602
  • 2006-001548-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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