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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: |
NCT02297490 |
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Date of registration:
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12/11/2014 |
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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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Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials
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Scientific title:
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Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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158 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02297490 |
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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: Basic Science. 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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Canada
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Contacts
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Name:
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Piyush Patel, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic
asthma
- positive skin prick test
- specific IgE = 0.70 kU/L to mixture of grass pollen allergens
- symptom score of at least 4 per day during the week following the peak-pollen count in
the baseline season
Exclusion Criteria:
- undergone previous specific immunotherapy with grass pollen allergens in any
formulation less than 5 years prior to the screening date
- currently undergoing any sort of immunotherapy, or has ever undergone specific
immunotherapy with unknown allergen
- allergens which are expected to interfere with the grass pollen season
- uncontrolled or partly controlled asthma
- patients with contraindications for SIT
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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Healthy Volunteers
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Allergic Rhinoconjunctivitis
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Intervention(s)
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Drug: Placebo
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Biological: Allergovit 6-grasses
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Primary Outcome(s)
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Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)
[Time Frame: Grass pollen season from March until July (approx. 11 weeks avarage)]
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Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)
[Time Frame: Grass pollen season from March until July (approx. 11 weeks avarage)]
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Total Symptom Score (TSS)
[Time Frame: 1 year]
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Secondary Outcome(s)
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Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects
[Time Frame: 1 year]
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Secondary ID(s)
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AL13BP01
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AL1304AV
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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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