Technical and clinical validation of the Allergen BioCube^® for timothy grass

Abstract

IntroductionField studies for allergic rhinitis (AR) commonly have inconsistent allergen concentrations and subject exposure patterns due to varying environmental conditions and subject behaviors. A technical and clinical validation study was conducted for the Allergen BioCube® using timothy grass to confirm uniform allergen concentration and clinically relevant subject symptom responses.MethodsAllergen concentrations were verified by laser particle counts. Subjects (N = 14) with positive skin test reactions and no symptoms at screening received four 3‐h timothy grass exposures in the BioCube over consecutive days. Subjects evaluated nasal itching, sneezing, rhinorrhea, and nasal congestion while in the BioCube; Total Nasal Symptom Score (TNSS) was computed. Peak Nasal Inspiratory Flow (PNIF), Peak Expiratory Flow Rate (PEFR), sIgE blood tests, and Nasal Inflammation Score (NIS) were assessed. A correlation analysis was conducted for mean sIgE, skin test, and TNSS.ResultsUniform timothy grass concentrations were achieved in the BioCube, both spatially and temporally, at all subject positions. Mean TNSS increased substantially from pre‐exposure levels (0.36 ± 0.74 to 1.86 ± 2.14) to maximums of 7.07 ± 2.76 at 1.5 h and 6.71 ± 2.70 at 3 h BioCube exposure. Twelve (86%) subjects had TNSS increases ≥6 units. PNIF decreased 12–24% from baseline at 3‐h BioCube exposure. NIS increased (baseline = 0) to 3.7 (maximum score = 4). A low/moderate correlation (r = 0.485) occurred between mean sIgE blood levels and mean skin tests; neither sIgE or skin tests correlated with mean TNSS. However, subjects with high skin test scores or positive blood IgE tended to also have higher TNSS.ConclusionsThe Allergen BioCube achieved technical and clinical validation for uniform timothy grass concentration and clinically meaningful AR sign and symptom responses. The Allergen BioCube can be used to assess the efficacy of therapies for reduction of AR signs and symptoms resulting from grass exposure.

<p>Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube^&reg;:&nbsp;a randomized clinical trial</p>

“…AR signs, evaluated by the investigator as secondary end points, included peak nasal inspiratory flow (PNIF), measured every 60 minutes during ragweed pollen exposure in the BioCube. Due to PNIF differences between the treatment groups throughout the study, a post-hoc PNIF percent change from baseline (CFB) analysis was conducted 7. PNIF measurements were performed in a masked manner, with the investigator not aware of which study medication (ie, drug or placebo) each subject received.…”

“…Environmental exposure units (EEUs), first developed in the 1980s, allow for allergen specificity, control over antigen exposure levels, temperature, and air quality, and provide an accurate way of tracking self-reported and physician-observed symptoms for determining response to medication. The Allergen BioCube ® (ABC ® ) is an EEU that has been technically and clinically validated for both Timothy-grass7 and ragweed8 exposures.…”

Iodixanol Nasal Solution Reduces Allergic Rhinoconjunctivitis Signs and Symptoms in Allergen BioCube®: Randomized Clinical Trial

“…Similarly, in the current iodixanol study, mean TNSS increased 5.05 units from pre-to post-BioCube exposure, further validating the reproducibility of the BioCube. Technical and/or clinical validation studies of the BioCube were also performed prior to this study for timothy grass [7] and induction of allergic signs and symptoms similar to pollen exposure in the environment [13].…”

“…Environmental exposure units (EEUs), fi rst developed in the 1980s are allow for allergen specifi city, control over antigen exposure levels, temperature, and air quality, and provide an accurate way of tracking self-reported and physician-observed symptoms for determining response to medication. The Allergen BioCube ® (ABC) is an EEU that has been technically and clinically validated for both Timothy [7] and ragweed [8], exposures.…”

“…AR signs, evaluated by the investigator as secondary endpoints, included Peak Nasal Inspiratory Flow (PNIF), measured every 60 min during ragweed pollen exposure in the BioCube. Due to PNIF differences between the treatment groups throughout the study, a post hoc PNIF % change from baseline analysis was conducted[7]. PNIF measurements were performed in a masked manner, with the Investigator not aware of which study medication (ie, drug or placebo) each subject received.…”