Comparability and Standardization of Controlled Allergen Challenge Facilities
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | May 2016 |
Allergen challenge facilities have been utilized for many years in clinical drug trials
studying onset of action, proof of concept, duration of action, and efficacy. Each facility
has somewhat different design characteristics and pollen dispersal technologies. Facilities
are located in disparate geographic areas and have populations of participants who are
sensitized to allergens unique to that area. Therefore, facilities have operated as single
sites with little effort to evaluate facility comparability or to attempt standardization
across facilities. The purpose of this study is to compare the two sites and assess whether
the sites are able to achieve similar symptom scores.
studying onset of action, proof of concept, duration of action, and efficacy. Each facility
has somewhat different design characteristics and pollen dispersal technologies. Facilities
are located in disparate geographic areas and have populations of participants who are
sensitized to allergens unique to that area. Therefore, facilities have operated as single
sites with little effort to evaluate facility comparability or to attempt standardization
across facilities. The purpose of this study is to compare the two sites and assess whether
the sites are able to achieve similar symptom scores.
When CACF have been designed with a high degree of rigor, quality assurance and validation
testing, the exposure to controlled levels of pollen in such facilities as the Environmental
Exposure Unit (EEU) and the Biogenics Research Chamber (BRC) will demonstrate
comparable/standardized symptomatic responses. This will be demonstrable not only following
pollen exposure but will also have similar reductions in symptoms following treatment with a
Food and Drug Administration (FDA) approved medication known to be effective for the
treatment of seasonal allergic rhinoconjunctivitis ( SAR); cetirizine 10mg. Because of
quality assurance and validation testing completed at these facilities a priori, this
comparability will be demonstrated despite their disparate geographical physical locations
and the utilization of these facilities of somewhat different mechanical and technical
materials and methods to achieve similar outcomes.
This multi-center study of SAR will enroll 50 participants at each site. These participants
will be age 18-65, male and female, with a mixture of ethnic groups. The study will involve
3 Phases: Screening, Treatment Exposure Visit, and a cross-over Treatment Exposure Visit. In
all stages, a CACF visit will be pivotal to determine participant eligibility for enrollment
and response to therapy. The qualifying participants will receive a double-blinded,
placebo-controlled, crossover intervention with cetirizine HCl 10mg.
All participants will give written informed consent prior to any study related procedures
being performed. Participants who meet all inclusion/exclusion criteria during the screening
process will be asked to return to the EEU for their first pollen exposure visit (Treatment
Visit #1). At the Screening Visit participants will provide a full medical history and
undergo a physical examination. They will have their height/weight and vitals measured and
skin testing will be performed to confirm allergic response to a panel of common
aeroallergens. Women of child bearing potential will undergo a urine pregnancy test to rule
out pregnancy. Eligible participants will be invited back to the research centre for 4
pollen exposure visits at 2 of these visits participants will receive either cetirizine or
placebo. All participants will receive placebo at some point throughout the study.
testing, the exposure to controlled levels of pollen in such facilities as the Environmental
Exposure Unit (EEU) and the Biogenics Research Chamber (BRC) will demonstrate
comparable/standardized symptomatic responses. This will be demonstrable not only following
pollen exposure but will also have similar reductions in symptoms following treatment with a
Food and Drug Administration (FDA) approved medication known to be effective for the
treatment of seasonal allergic rhinoconjunctivitis ( SAR); cetirizine 10mg. Because of
quality assurance and validation testing completed at these facilities a priori, this
comparability will be demonstrated despite their disparate geographical physical locations
and the utilization of these facilities of somewhat different mechanical and technical
materials and methods to achieve similar outcomes.
This multi-center study of SAR will enroll 50 participants at each site. These participants
will be age 18-65, male and female, with a mixture of ethnic groups. The study will involve
3 Phases: Screening, Treatment Exposure Visit, and a cross-over Treatment Exposure Visit. In
all stages, a CACF visit will be pivotal to determine participant eligibility for enrollment
and response to therapy. The qualifying participants will receive a double-blinded,
placebo-controlled, crossover intervention with cetirizine HCl 10mg.
All participants will give written informed consent prior to any study related procedures
being performed. Participants who meet all inclusion/exclusion criteria during the screening
process will be asked to return to the EEU for their first pollen exposure visit (Treatment
Visit #1). At the Screening Visit participants will provide a full medical history and
undergo a physical examination. They will have their height/weight and vitals measured and
skin testing will be performed to confirm allergic response to a panel of common
aeroallergens. Women of child bearing potential will undergo a urine pregnancy test to rule
out pregnancy. Eligible participants will be invited back to the research centre for 4
pollen exposure visits at 2 of these visits participants will receive either cetirizine or
placebo. All participants will receive placebo at some point throughout the study.
Inclusion Criteria:
- history of rhyinoconjuctivitis during ragweed season for a minimum of 2 years,
including the previous 2 ragweed seasons.
- positive skin test to ragweed allergen.
Exclusion Criteria:
- participant is pregnant, lactating or actively trying to conceive.
- has a history of receiving immunotherapy containing short ragweed within the last 3
years.
- participant has current allergy symptoms.
We found this trial at
2
sites
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