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Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oralgen
grass pollen extract
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 - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MHAT PLovdiv, ENT Clinic
  • 5th MHAT, ENT Clinic
  • Military Medical Academy
  • Ministry of interior-central clinical database
  • MHAT Sveta Marina
  • Military Medical Academy
  • Fakultni nemocnice Brno
  • ORL Soukroma praxe
  • Nemocnice Caslav
  • Alergologicka ordinace
  • Alergologicka ambulance
  • Alergologicka ordinace
  • Alergologicka ambulance
  • Ambulance plicni a alergologicka
  • Alergologicka ambulance Okresni nemocnice Tabor
  • Berufsgen. kliniken Bergmannsheil
  • Univ. klinikum Carl Gustav Carus
  • MedicoKIT
  • Johannes-Gutenberg-Universitat Mainz
  • Vital Care
  • Privataertz. inst. & Forsh. einrichtung
  • Svabhegyi Allami Gyermekgyogyintezet pulmonologia
  • Szent Janos Korhaz
  • Selye Janos Korhaz
  • Karolina Korhaz
  • Tudogyogyintezet Torokbalint
  • Kaunas medical University hospital
  • Klaipeda Regional Hospital
  • JSC Seimos gydytojas
  • Vilnius Central Outpatient Clinic
  • Vilnius university hospital, Santariskiu Clinic
  • Ampha
  • Ampha
  • Ampha
  • Menox
  • Centrum imunologie a alergologie s.r.o
  • FNsP Nove Zamky, ambulancia TaRCh
  • Amb. klinickey imunologie a allergologie UTaRCH
  • Ambulancia klinickej imunologie a alergologie
  • Medcentrum s.r.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

grass pollen extract twice weekly

Grass pollen extract, daily

Increased dose of grass pollen extract

Placebo control

Arm Description

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.

Grass pollen immunotherapy, 9,500 BU, given daily

Increased dose of grass pollen immunotherapy, 19,000 BU, given daily

Patients randomized to placebo will receive placebo daily.

Outcomes

Primary Outcome Measures

Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)

Secondary Outcome Measures

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.

Full Information

First Posted
December 3, 2007
Last Updated
May 4, 2010
Sponsor
Artu Biologicals
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1. Study Identification

Unique Protocol Identification Number
NCT00567346
Brief Title
Efficacy and Safety of Grass Pollen Sublingual Immunotherapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Artu Biologicals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
605 (Actual)

8. Arms, Groups, and Interventions

Arm Title
grass pollen extract twice weekly
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Grass pollen extract, daily
Arm Type
Active Comparator
Arm Description
Grass pollen immunotherapy, 9,500 BU, given daily
Arm Title
Increased dose of grass pollen extract
Arm Type
Active Comparator
Arm Description
Increased dose of grass pollen immunotherapy, 19,000 BU, given daily
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
Patients randomized to placebo will receive placebo daily.
Intervention Type
Drug
Intervention Name(s)
Oralgen
Other Intervention Name(s)
grass pollen extract
Intervention Description
Patients will receive drops of grass pollen immunotherapy sublingually
Intervention Type
Drug
Intervention Name(s)
grass pollen extract
Other Intervention Name(s)
Placebo control
Intervention Description
Patients will receive matching placebo sublingually
Primary Outcome Measure Information:
Title
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
Time Frame
One year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Folkert R Roossien
Organizational Affiliation
Artu-Biologicals Europe B.V., the Netherlands
Official's Role
Study Director
Facility Information:
Facility Name
MHAT PLovdiv, ENT Clinic
City
Plovdiv
Country
Bulgaria
Facility Name
5th MHAT, ENT Clinic
City
Sofia
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
Ministry of interior-central clinical database
City
Sofia
Country
Bulgaria
Facility Name
MHAT Sveta Marina
City
Varna
Country
Bulgaria
Facility Name
Military Medical Academy
City
Varna
Country
Bulgaria
Facility Name
Fakultni nemocnice Brno
City
Brno-Bohunice
Country
Czech Republic
Facility Name
ORL Soukroma praxe
City
Brno
Country
Czech Republic
Facility Name
Nemocnice Caslav
City
Caslav
Country
Czech Republic
Facility Name
Alergologicka ordinace
City
Dobruska
Country
Czech Republic
Facility Name
Alergologicka ambulance
City
Jablonec nad Nisou
Country
Czech Republic
Facility Name
Alergologicka ordinace
City
Kutna Hora
Country
Czech Republic
Facility Name
Alergologicka ambulance
City
Ostrava - Hrabuvka
Country
Czech Republic
Facility Name
Ambulance plicni a alergologicka
City
Ostrave - Hrabuvka
Country
Czech Republic
Facility Name
Alergologicka ambulance Okresni nemocnice Tabor
City
Tabor
Country
Czech Republic
Facility Name
Berufsgen. kliniken Bergmannsheil
City
Bochum
Country
Germany
Facility Name
Univ. klinikum Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
MedicoKIT
City
Goch
Country
Germany
Facility Name
Johannes-Gutenberg-Universitat Mainz
City
Mainz
Country
Germany
Facility Name
Vital Care
City
Muenchen
Country
Germany
Facility Name
Privataertz. inst. & Forsh. einrichtung
City
Wiesbaden
Country
Germany
Facility Name
Svabhegyi Allami Gyermekgyogyintezet pulmonologia
City
Budapest
Country
Hungary
Facility Name
Szent Janos Korhaz
City
Budapest
Country
Hungary
Facility Name
Selye Janos Korhaz
City
Komarom
Country
Hungary
Facility Name
Karolina Korhaz
City
Mosomagyarovar
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
Country
Hungary
Facility Name
Kaunas medical University hospital
City
Kaunas
Country
Lithuania
Facility Name
Klaipeda Regional Hospital
City
Klaipeda
Country
Lithuania
Facility Name
JSC Seimos gydytojas
City
Vilnius
Country
Lithuania
Facility Name
Vilnius Central Outpatient Clinic
City
Vilnius
Country
Lithuania
Facility Name
Vilnius university hospital, Santariskiu Clinic
City
Vilnius
Country
Lithuania
Facility Name
Ampha
City
De Bilt
Country
Netherlands
Facility Name
Ampha
City
Den Bosch
Country
Netherlands
Facility Name
Ampha
City
Hengelo
Country
Netherlands
Facility Name
Menox
City
Nijmegen
Country
Netherlands
Facility Name
Centrum imunologie a alergologie s.r.o
City
Bratislava
Country
Slovakia
Facility Name
FNsP Nove Zamky, ambulancia TaRCh
City
Nove Zamky
Country
Slovakia
Facility Name
Amb. klinickey imunologie a allergologie UTaRCH
City
Poprad
Country
Slovakia
Facility Name
Ambulancia klinickej imunologie a alergologie
City
Trencin
Country
Slovakia
Facility Name
Medcentrum s.r.o.
City
Zilina
Country
Slovakia

12. IPD Sharing Statement

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Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

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