Roflumilast, a phosphodiesterase 4 inhibitor, reduces airway hyperresponsiveness after allergen challenge

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dc.contributor.authorLouw C.
dc.contributor.authorWilliams Z.
dc.contributor.authorVenter L.
dc.contributor.authorLeichtl S.
dc.contributor.authorSchmid-Wirlitsch C.
dc.contributor.authorBredenbroker D.
dc.contributor.authorBardin P.G.
dc.date.accessioned2011-05-15T15:57:31Z
dc.date.available2011-05-15T15:57:31Z
dc.date.issued2007
dc.description.abstractBackground: Roflumilast, an oral, once-daily phosphodiesterase 4 inhibitor, is currently in clinical development for the treatment of asthma. Objectives: This pilot study examined the effect of roflumilast on allergen-induced airway hyperresponsiveness (AHR) to histamine challenge and asthmatic response to allergen challenge. Methods: In a randomized, double-blind, 2-period, crossover trial, 13 patients with mild allergic asthma [mean forced expiratory volume in 1 s (FEV1) % predicted = 86%] received a single dose of oral roflumilast 1,000 μg or placebo. Patients were administered roflumilast 60 min before allergen challenge, and asthmatic responses were assessed via change in FEV1 ≤9 h after allergen challenge. AHR to histamine provocation was measured before and repeated 24 h after allergen provocation. Patients inhaled histamine in doubling concentrations until attaining a decrease in FEV1 of ≤20% (PC20FEV1). Results: Roflumilast had no detectable bronchodilator activity 60 min after administration. Roflumilast significantly attenuated AHR compared with placebo, with a mean change in pre- to postallergen challenge PC20FEV 1 ratio of 1.23 ± 2.75 and 2.51 ± 2.95 for roflumilast and placebo, respectively (p = 0.002). During the late asthmatic response, roflumilast reduced the mean maximum decrease in FEV1 from 2 to 9 h after allergen challenge compared with placebo (p = 0.005). Additionally, FEV1 at 9 h after challenge was significantly higher in patients treated with roflumilast (p = 0.03). Early asthmatic responses to allergen challenge were not significantly reduced by the single dose of roflumilast. Conclusions: Roflumilast attenuated allergen-induced AHR in patients with mild asthma. These results support further investigation of roflumilast as an anti-inflammatory treatment of asthma. Copyright © 2006 S. Karger AG.
dc.description.versionArticle
dc.identifier.citationRespiration
dc.identifier.citation74
dc.identifier.citation4
dc.identifier.issn257931
dc.identifier.other10.1159/000095677
dc.identifier.urihttp://hdl.handle.net/10019.1/10452
dc.subjectallergen
dc.subjecthistamine
dc.subjectphosphodiesterase IV inhibitor
dc.subjectplacebo
dc.subjectroflumilast
dc.subjectabdominal pain
dc.subjectadult
dc.subjectallergic asthma
dc.subjectarticle
dc.subjectbronchodilatation
dc.subjectclinical article
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectDermatophagoides pteronyssinus
dc.subjectdisease severity
dc.subjectdizziness
dc.subjectdouble blind procedure
dc.subjectdrug activity
dc.subjectdrug efficacy
dc.subjectdrug fever
dc.subjectdrug induced headache
dc.subjectforced expiratory volume
dc.subjecthuman
dc.subjectmale
dc.subjectnausea
dc.subjectnervousness
dc.subjectprick test
dc.subjectpriority journal
dc.subjectprovocation test
dc.subjectpruritus
dc.subjectrandomized controlled trial
dc.subjectside effect
dc.subjectsingle drug dose
dc.subjectsomnolence
dc.subjectstatistical significance
dc.subjecttachycardia
dc.subjectAdministration, Oral
dc.subjectAdolescent
dc.subjectAdult
dc.subjectAllergens
dc.subjectAminopyridines
dc.subjectBenzamides
dc.subjectBronchial Hyperreactivity
dc.subjectBronchial Provocation Tests
dc.subjectCross-Over Studies
dc.subjectCyclopropanes
dc.subjectDose-Response Relationship, Drug
dc.subjectDouble-Blind Method
dc.subjectFollow-Up Studies
dc.subjectForced Expiratory Volume
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectPhosphodiesterase Inhibitors
dc.subjectPilot Projects
dc.subjectTreatment Outcome
dc.titleRoflumilast, a phosphodiesterase 4 inhibitor, reduces airway hyperresponsiveness after allergen challenge
dc.typeArticle
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