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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02943720 |
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Date of registration:
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21/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
ATIBAR |
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Scientific title:
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A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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421 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02943720 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Finland
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Germany
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Lithuania
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Norway
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Poland
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Slovakia
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Sweden
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Contacts
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Name:
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Stephen Durham, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NHLI, Imperial College London |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult subjects 18 to 65 yrs old, male or female
- moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the
two preceding birch pollen seasons
- positive Skin Prick Test (SPT) to birch pollen extract
- positive specific IgE CAP to Bet v1.
Exclusion Criteria:
- persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted),
- previous specific immunotherapy (SIT) to tree pollens,
- previous SIT to any allergen within 5 years,
- previous history of severe anaphylactic reaction,
- perennial allergic Rhinitis/Rhinoconjunctivitis,
- other disorder possibly influencing the trial outcomes,
- pregnancy,
- any severely debilitating disease,
- primary or secondary immunodeficiency or treatment with immunosuppressor drugs within
one month prior to randomization (oral steroids, other immunosuppressors).
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Allergic Rhinitis
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Intervention(s)
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Drug: AllerT
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Drug: placebo
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Primary Outcome(s)
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Combined Symptom and Medication Score (CSMS)
[Time Frame: 2 to 6 months after the end of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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