- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901914
Study of rBet v1 Tablets
June 26, 2013 updated by: Stallergenes Greer
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
483
Phase
- Phase 2
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
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Copenhagen, Denmark, 2100
- National University Hospital - Allergy Unit 4222
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Helsinki, Finland, 00029
- Helsingin Yliopistollinen Keskussairaala
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Strasbourg, France, 67091
- NHC, Hôpitaux Universitaires de Strasbourg
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Berlin, Germany, 10117
- Charite Universitaetsmedizin
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Kaunas, Lithuania, 50009
- Public Institution Kaunas Medical University Hospital
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Lodz, Poland, 90-153
- SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
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Moscow, Russian Federation, 115478
- Institute of Immunology of FMBA
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Gothenburg, Sweden, 413 45
- Sabina RAK
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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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 1
Placebo
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One sublingual tablet of matching placebo daily during approximately 5.5 months
Other Names:
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Experimental: 2
12.5 µg rBet v 1
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One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Names:
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Names:
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Names:
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Experimental: 3
25 µg rBet v 1
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One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Names:
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Names:
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Names:
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Experimental: 4
50 µg rBet v 1
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One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
Other Names:
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
Other Names:
One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Average Adjusted Symptom Score
Time Frame: ~1 month (whole birch pollen season)
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~1 month (whole birch pollen season)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Average Rhinoconjunctivitis Total symptom Score
Time Frame: ~1 month (whole birch pollen season)
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~1 month (whole birch pollen season)
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Rescue Medication Score
Time Frame: ~1 month (whole birch pollen season)
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~1 month (whole birch pollen season)
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Average Combined Score
Time Frame: ~1 month (whole birch pollen season)
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~1 month (whole birch pollen season)
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Proportion of symptom-controlled days
Time Frame: ~1 month (whole birch pollen season)
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~1 month (whole birch pollen season)
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Global evaluation by the patient
Time Frame: after 5-6 months of treatment
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after 5-6 months of treatment
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Immunological markers (IgE and IgG4)
Time Frame: 6-7 months
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6-7 months
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Sensitisation status
Time Frame: At least 6 months
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At least 6 months
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Lower airways symptoms
Time Frame: ~1 month (whole birch pollen season)
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~1 month (whole birch pollen season)
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Safety assessments
Time Frame: 6-7 months
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6-7 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sabina Rak, MD. PR, Sahlgrenska University Hospital, Department of Respiratory Medicine and Allergy, 413 45 Gothenburg, Sweden
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
October 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
April 28, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (Estimate)
May 14, 2009
Study Record Updates
Last Update Posted (Estimate)
June 27, 2013
Last Update Submitted That Met QC Criteria
June 26, 2013
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VO59.08
- 2007-007869-21 (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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