Environmental exposure unit: a system to test anti-allergic treatment

Day, James H.; Briscoe, Maureen P.

doi:10.1016/s1081-1206(10)62616-6

Cited by 53 publications

(38 citation statements)

References 18 publications

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“…The EEU is a well-validated and internationally recognized controlled allergen challenge facility located in Kingston, ON Canada [14-16]. The EEU allows for large groups of clinical trial participants to be simultaneously exposed to controlled levels of airborne allergens such as ragweed or grass pollen.…”

Section: Introductionmentioning

confidence: 99%

“…With the ability to control these variables, study conditions can be reproduced on different days at any time of the year with the same or different study participants, something that cannot be achieved with any other research model for allergic rhinitis. Utilizing this model thus yields more precise results for direct comparisons of different treatment modalities [14]. Over the past decade, the EEU has gained international acceptance for the clinical research conducted in Kingston with over 20 publications in top research journals (recent references indicated) [17-23].…”

Section: Introductionmentioning

confidence: 99%

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A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis

Ellis

Zhu

Walker

et al. 2013

All Asth Clin Immun

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BackgroundAzelastine has been shown to be effective against seasonal allergic rhinitis (SAR). The Environmental Exposure Unit (EEU) is a validated model of experimental SAR. The objective of this double-blind, four-way crossover study was to evaluate the onset of action of azelastine nasal spray, versus the oral antihistamines loratadine 10 mg and cetirizine 10 mg in the relief of the symptoms of SAR.Methods70 participants, aged 18-65, were randomized to receive azelastine nasal spray, cetirizine, loratadine, or placebo after controlled ragweed pollen exposure in the EEU. Symptoms were evaluated using the total nasal symptom score (TNSS). The primary efficacy parameter was the onset of action as measured by the change from baseline in TNSS.ResultsAzelastine displayed a statistically significant improvement in TNSS compared with placebo at all time points from 15 minutes through 6 hours post dose. Azelastine, cetirizine, and loratadine reduced TNSS compared to placebo with an onset of action of 15 (p < 0.001), 60 (p = 0.015), and 75 (p = 0.034) minutes, respectively. The overall assessment of efficacy was rated as good or very good by 46% of the participants for azelastine, 51% of the participants for cetirizine, and 30% of the participants for loratadine compared to 18% of the participants for placebo.ConclusionsAzelastine’s onset of action for symptom relief was faster than that of cetirizine and loratadine. The overall participant satisfaction in treatment with azelastine is comparable to cetirizine and statistically superior to loratadine. These results suggest that azelastine may be preferential to oral antihistamines for the rapid relief of SAR symptoms.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis

Ellis

Zhu

Walker

et al. 2013

All Asth Clin Immun

View full text Add to dashboard Cite

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“…Some early EEU studies experienced insufficient control of allergen release or had differing onset of action results for the same drug 4. These issues have been addressed in EEUs currently in use with system controls.…”

Section: Discussionmentioning

confidence: 99%

“…One of the first EEUs, the EEU in Canada,4 was initially used in the early 1980s to evaluate the respiratory effects of urea formaldehyde foam insulation and was adapted in 1987 for allergy research. Other EEUs have included the Vienna Challenge Chamber in Austria;5 the Denmark chamber;6 the Fraunhofer Institute Environmental Challenge Chamber in Germany;7 the GA 2 LEN chamber in Germany;8 the OHIO, Wakayama, and Osaka/Chiba units in Japan;9–11 the Environmental Exposure Chamber in Canada;12 allergen Challenge Theatre in Canada;13 and the Atlanta Allergen Exposure Unit,14 the Allergen BioCube,15 and the Biogenics Research Chamber16 in the US.…”

Section: Introductionmentioning

confidence: 99%

Technical and clinical validation of an environmental exposure unit for ragweed

Gomes¹,

Lane²,

Angjeli³

et al. 2016

JAA

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BackgroundAllergic rhinitis is a common condition, with ragweed pollen one of the more prevalent aeroallergens. Environmental exposure units such as the Allergen BioCube® are valuable models for clinical allergy studies. A study was conducted to validate the Allergen BioCube for uniform ragweed pollen concentrations and clinically relevant sign and symptom responses to ragweed exposure.MethodsRagweed pollen concentrations were measured on 3 consecutive days in the Allergen BioCube and verified by Rotorod collection and continuous laser particle count measurements. Subjects (N=10) were exposed to ragweed pollen in the BioCube for 3 hours per day for 3 consecutive days. Subjects assessed their nasal itching, sneezing, rhinorrhea, and nasal congestion during each BioCube exposure; total nasal symptom score was computed. Peak nasal inspiratory flow was also assessed during BioCube exposure.ResultsUniform ragweed pollen concentrations were obtained throughout each of the 3-hour testing periods in the Allergen BioCube, both spatially and temporally, at all subject positions, with a low mean standard deviation of 10%. Pronounced increases in mean total nasal symptom scores (6.7±0.94 to 7.6±0.86, last 90 minutes of exposure) occurred for all three BioCube ragweed pollen exposure visits. Mean peak nasal inspiratory flow decreased 24% at 3 hours of BioCube exposure on Day 3. No safety issues of concern occurred in this study.ConclusionThe Allergen BioCube achieved technical and clinical validation for ragweed allergen. Ragweed pollen concentration was uniform both temporally and spatially. Allergic rhinitis signs and symptoms were induced in subjects during exposure to ragweed in the BioCube at clinically meaningful levels for allergy studies.

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“…Instead, we employed the EEU to allow larger numbers of study volunteers to be simultaneously exposed to standardized ambient levels of ragweed pollen, providing the recognized advantage of a more natural mode of allergen exposure [18]. Ragweed allergen was chosen, as it is one of the most common aeroallergens that naturally induces allergic rhinitis symptoms in our study population, and the level of exposure in the EEU was consistent with peak seasonal levels [23,24]. European annual mean pollen counts of ragweed are as high as 7800 grains/m 3 [3,25].…”

Section: Discussionmentioning

confidence: 99%

Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit

North

Walker

Steacy

et al. 2014

All Asth Clin Immun

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BackgroundOral antihistamines that target the histamine receptor–1, such as fexofenadine, offer suboptimal relief of allergic rhinitis-associated nasal congestion. Combinations with oral sympathomimetics, such as pseudoephedrine, relieve congestion but produce side effects. Previous animal and human studies with histamine receptor-3 antagonists, such as PF-03654764, demonstrate promise.MethodsHerein we employ the Environmental Exposure Unit (EEU) to conduct the first randomized controlled trial of PF-03654764 in allergic rhinitis. 64 participants were randomized in a double-blind, placebo-controlled 4-period crossover study. Participants were exposed to ragweed pollen for 6 hours post-dose in the EEU. The primary objective was to compare the effect of PF-03654764 + fexofenadine to pseudoephedrine + fexofenadine on the subjective measures of congestion and Total Nasal Symptom Score (TNSS). The objectives of our post-hoc analyses were to compare all treatments to placebo and determine the onset of action (OA). This trial was registered at ClinicalTrials.gov (NCT01033396).ResultsPF-03654764 + fexofenadine was not superior to pseudoephedrine + fexofenadine. In post-hoc analyses, PF-03654764 + fexofenadine significantly reduced TNSS, relative to placebo, and OA was 60 minutes. Pseudoephedrine + fexofenadine significantly reduced congestion and TNSS, relative to placebo, with OA of 60 and 30 minutes, respectively. Although this study was not powered for a statistical analysis of safety, it was noted that all PF-03654764-treated groups experienced an elevated incidence of adverse events.ConclusionsPF-03654764 + fexofenadine failed to provide superior relief of allergic rhinitis-associated nasal symptoms upon exposure to ragweed pollen compared to fexofenadine + pseudoephedrine. However, in post-hoc analyses, PF-03654764 + fexofenadine improved TNSS compared to placebo. Side effects in the PF-03654764-treated groups were clinically significant compared to the controls.

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Environmental exposure unit: a system to test anti-allergic treatment

Cited by 53 publications

References 18 publications

A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis

A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis

Technical and clinical validation of an environmental exposure unit for ragweed

Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit

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