- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02297490
Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials
Evaluation of the Utility of an Environmental Exposure Chamber (EEC) for Assessing Efficacy of Specific Immunotherapy (SIT) in Pivotal Clinical Trials
The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC).
There are 2 treatments in this study. Both treatments are injected under the skin. Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before the grass pollen season begins which may lead to decreased sensitivity and reduced allergy symptoms during the grass season. Placebo treatment does not contain grass pollen mixture, and is not expected to reduce allergic symptoms overtime.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, L4W 1A4
- Inflamax Research INC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Placebo treatment is identical to the active treatment schedule.
The placebo-preparation used is identical to the active solution but without any allergen substance in it.
|
Placebo treatment is identical to the active treatment schedule.
The placebo-preparation used is identical to the active solution but without any allergen substance in it.
Other Names:
|
EXPERIMENTAL: Allergovit 6-grasses immunotherapy
Immunotherapy will be performed for approx.
5 months.
7 injections will be administered at weekly intervals to reach the maintenance dose.
However, dosing must be individualised.
|
Immunotherapy will be performed for approx.
5 months.
7 injections will be administered at weekly intervals to reach the maintenance dose.
However, dosing must be individualised.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Symptom Score (TSS)
Time Frame: 1 year
|
Analysis of the relationship between different methods of measurement of efficacy of SIT. The AUC of the Total Symptom Score (TSS) as primary endpoint assessed in an EEC after preseasonal treatment |
1 year
|
Rhinoconjunctivitis Symptom and Medication Score (RC-SMS)
Time Frame: Grass pollen season from March until July (approx. 11 weeks avarage)
|
The AUC of the Rhinoconjunctivitis Symptom and Medication Score (RC-SMS) assessed as primary endpoint during the natural grass pollen season (field-based)
|
Grass pollen season from March until July (approx. 11 weeks avarage)
|
Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS)
Time Frame: Grass pollen season from March until July (approx. 11 weeks avarage)
|
The AUC of the Medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) assessed as primary endpoint during the natural grass pollen season (field-based)
|
Grass pollen season from March until July (approx. 11 weeks avarage)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms (by TSS, RC-SMS, ma-RC-SS) in non-allergic subjects
Time Frame: 1 year
|
Evaluation of the relationship of symptoms experienced in EEC and natural grass pollen season.
Assessment of symptom specificity provoked by EEC in non-allergic subjects.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Piyush Patel, Dr.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AL1304AV
- AL13BP01 (OTHER: Inflamax Research INC.)
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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