Onset of action, efficacy, and safety of fexofenadine 60 mg/pseudoephedrine 120 mg versus placebo in the Atlanta allergen exposure unit

Berkowitz, Ruth; Woodworth, George; Lutz, Cheryl; Weiler, Kay; Weiler, John M.; Moss, Madelyn; Meeves, Suzanne

doi:10.1016/s1081-1206(10)61909-6

Cited by 34 publications

(20 citation statements)

References 17 publications

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“…the Vienna Challenge Chamber in Austria [6], the Environmental Exposure Unit in Canada [7, 8] and Germany [9], and the allergen exposure unit in the US [10]. Clinical efficacies and onset and duration of action of antiallergic drugs have been investigated in patients with allergic rhinitis at each facility.…”

Section: Introductionmentioning

confidence: 99%

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Hashiguchi

Tang²,

Fujita³

et al. 2009

Int Arch Allergy Immunol

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Background: An artificial exposure chamber (OHIO Chamber), which allows dispersal of a fixed concentration of Japanese cedar (JC) pollen under stable conditions, was constructed. This study was conducted to identify the exposure conditions assuring validity of the clinical tests conducted using this chamber. Methods: Twenty-four adult patients with JC pollinosis were exposed to different concentrations of JC pollen: 0 (only during the summer period), 4,000, 8,000 and 12,000 grains/m³, and the nasal and ocular symptoms were self-assessed during a 4-hour period of exposure. The amount of nasal discharge was measured and the sneezing frequency was recorded. This study was conducted twice during the summer and winter periods, i.e. non-pollen seasons. The reproducibility of the symptoms between the two seasons was assessed. Results: None of the subjects developed any symptom at the pollen concentration of 0 grains/m³. No significant differences in the time to the onset of symptoms were found between the summer and winter study, regardless of the pollen concentration. There were no significant differences between the summer and winter study in the total symptom score and total nasal symptom score at any pollen concentration, suggesting the very favorable reproducibility of symptoms. Conclusions: Efficient and reproducible results are obtained in patients exposed to JC pollen in the OHIO Chamber. The results suggest the conditions of JC pollen exposure have scientific validity and the OHIO Chamber has the potential to contribute significantly to basic and clinical studies of JC pollinosis.

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Section: Introductionmentioning

confidence: 99%

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Hashiguchi

Tang²,

Fujita³

et al. 2009

Int Arch Allergy Immunol

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“…Environmental exposure chamber studies can offer the advantage of inducing allergic rhinoconjunctivitis after exposure to pollen in the context of a highly controlled environment. [1][2][3][4][5][6] This strategy might potentially mitigate uncontrolled confounding factors that are inherent in phase III therapy trials conducted in sensitive subjects during the natural allergy season (eg, variable exposure to pollen or a short in-season period). 6 However, there are 2 key knowledge gaps that need to be bridged before this goal can be achieved.…”

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confidence: 99%

Responses to ragweed pollen in a pollen challenge chamber versus seasonal exposure identify allergic rhinoconjunctivitis endotypes

Jacobs

Harper

et al. 2012

Journal of Allergy and Clinical Immunology

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“…We previously found that fexofenadine alone provided clinically important relief from allergic rhinitis symptoms at 60 minutes [29]. The onset of action for fexofenadine + pseudoephedrine has been previously reported by Berkowitz et al to be 45 minutes [30]. Differences in reported onset of action likely result from timing of diary card collection and the symptoms included in composite scores.…”

Section: Discussionmentioning

confidence: 95%

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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Onset of action, efficacy, and safety of fexofenadine 60 mg/pseudoephedrine 120 mg versus placebo in the Atlanta allergen exposure unit

Cited by 34 publications

References 17 publications

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Validation Study of the OHIO Chamber in Patients with Japanese Cedar Pollinosis

Responses to ragweed pollen in a pollen challenge chamber versus seasonal exposure identify allergic rhinoconjunctivitis endotypes

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

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