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Study of rBet v1 Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901914
First Posted: May 14, 2009
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Quintiles, Inc.
Aptuit Inc.
Information provided by:
Stallergenes Greer
  Purpose
The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.

Condition Intervention Phase
Birch Pollen-related Rhinoconjunctivitis Rhinitis, Allergic, Seasonal Biological: Placebo Biological: rBet v 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis

Further study details as provided by Stallergenes Greer:

Primary Outcome Measures:
  • Average Adjusted Symptom Score [ Time Frame: ~1 month (whole birch pollen season) ]

Secondary Outcome Measures:
  • Average Rhinoconjunctivitis Total symptom Score [ Time Frame: ~1 month (whole birch pollen season) ]
  • Rescue Medication Score [ Time Frame: ~1 month (whole birch pollen season) ]
  • Average Combined Score [ Time Frame: ~1 month (whole birch pollen season) ]
  • Proportion of symptom-controlled days [ Time Frame: ~1 month (whole birch pollen season) ]
  • Global evaluation by the patient [ Time Frame: after 5-6 months of treatment ]
  • Immunological markers (IgE and IgG4) [ Time Frame: 6-7 months ]
  • Sensitisation status [ Time Frame: At least 6 months ]
  • Lower airways symptoms [ Time Frame: ~1 month (whole birch pollen season) ]
  • Safety assessments [ Time Frame: 6-7 months ]

Enrollment: 483
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Biological: Placebo
One sublingual tablet of matching placebo daily during approximately 5.5 months
Other Name: Placebo control
Experimental: 2
12.5 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Name: rBet v 1.0101
Experimental: 3
25 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Name: rBet v 1.0101
Experimental: 4
50 µg rBet v 1
Biological: rBet v 1
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Name: rBet v 1.0101

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the last 2 pollen seasons
  • Sensitisation to birch pollen as demonstrated, at screening, by a positive SPT to birch pollen with wheal diameter greater than 3 mm and specific IgE levels > 0.70 kU/L (birch pollen and rBet v 1)
  • Patients asymptomatic to all other allergens during the birch pollen season
  • RRTSS during the previous pollen season ≥ 12 out of a maximum possible score of 18
  • Patients with an FEV1 ≥ 80% of the predicted value
  • Female patients with no childbearing potential
  • Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method and have a negative urine pregnancy test, and are willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy during this study
  • Patients able to be compliant with respect to the completion of the daily record card and taking of the investigational products
  • Patients having provided signed informed consent

Exclusion Criteria:

  • Patients with symptoms of rhinoconjunctivitis during the birch pollen season due to non-birch-related allergens
  • Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to house dust mites
  • Patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study
  • Patients who previously received desensitisation treatment to birch pollen and/or another Betulaceae sp. within the previous 10 years
  • Patients with asthma (except birch seasonal asthma in which case the patient could be included in the study)
  • Patients with any nasal or oral condition that could interfere with efficacy or safety assessments (such as nasal polyposis or oral inflammation)
  • Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or outcome of this study
  • Any disease or condition which would place a patient at undue risk by being included in the study (according to the investigator's opinion)
  • Usual contra-indications of immunotherapy such as concomitant local or systemic beta-blocker therapy and/or immunosuppressive drugs
  • Patients with ongoing treatment by immunotherapy with another allergen
  • Patients treated with inhaled/systemic steroids within 4 weeks prior to Screening, or with long acting systemic corticosteroids 12 weeks before Screening
  • Patients under continuous corticotherapy or undergoing chronic treatment with H2-antihistamine drugs
  • Known hypersensitivity to mannitol
  • Pregnancy, breast-feeding/lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method
  • Patients with a history of drug or alcohol abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901914


Locations
Denmark
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark, 2100
Finland
Helsingin yliopistollinen keskussairaala
Helsinki, Finland, 00029
France
NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Germany
Charité universitaetsmedizin
Berlin, Germany, 10117
Lithuania
Public Institution Kaunas Medical University Hospital
Kaunas, Lithuania, 50009
Poland
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, Poland, 90-153
Russian Federation
Institute of Immunology of FMBA
Moscow, Russian Federation, 115478
Sweden
Sabina RAK
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Stallergenes Greer
Quintiles, Inc.
Aptuit Inc.
Investigators
Principal Investigator: Sabina Rak, MD. PR Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden
  More Information

Responsible Party: Bruno ROBIN, Stallergenes SA
ClinicalTrials.gov Identifier: NCT00901914     History of Changes
Other Study ID Numbers: VO59.08
2007-007869-21 ( EudraCT Number )
First Submitted: April 28, 2009
First Posted: May 14, 2009
Last Update Posted: June 27, 2013
Last Verified: February 2010

Keywords provided by Stallergenes Greer:
Hypersensitivity
Allergy
Birch, allergy, Sublingual Immunotherapy

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases