Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

This study has been completed.
Sponsor:
Information provided by:
Artu Biologicals
ClinicalTrials.gov Identifier:
NCT00567346
First received: December 3, 2007
Last updated: May 4, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Drug: Oralgen
Drug: grass pollen extract
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Artu Biologicals:

Primary Outcome Measures:
  • Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS) [ Time Frame: One year ] [ Designated as safety issue: No ]

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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 605
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Placebo control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567346

  Show 40 Study Locations
Sponsors and Collaborators
Artu Biologicals
Investigators
Study Director: Folkert R Roossien Artu-Biologicals Europe B.V., the Netherlands
  More Information

No publications provided

Responsible Party: Dr. F.F. Roosien, Artu Biologicals
ClinicalTrials.gov Identifier: NCT00567346     History of Changes
Other Study ID Numbers: AB0602, 2006-001548-30
Study First Received: December 3, 2007
Last Updated: May 4, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Paul-Ehrlich-Institut
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Artu Biologicals:
randomised
double-blind
placebo-controlled
efficacy and safety
Oralgen® Grass Pollen
allergic rhinoconjunctivitis
Allergy
Rhinoconjunctivitis
Immunotherapy
Grass pollen extract

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014