A phase IIa single-centre, randomised, double-blind, placebo-controlled, two-way cross-over allergen challenge study to evaluate the effect of treatment with once daily AQX-1125 on the late asthmatic response (LAR) to Inhaled Allergen Challenge (IAC) in subjects with mild to moderate atopic asthma. - Allergen Challenge Phase IIa Study

AQUINOX PHARMACEUTICALS INC0 个研究点开始时间: 2011年8月31日最近更新: 2012年6月26日

试验速览

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•1.Documented history of bronchial asthma, at least 6 months prior to the Screening Visit 1 and treated only with intermittent short-acting ß2 agonist therapy, by inhalation.
•2.Pre-bronchodilator FEV1=70% of predicted at Screening Visit 1.
•3.Demonstration of a positive wheal reaction on skin prick testing at screening, or within 12 months of screening.
•4.Screening IAC demonstrating that the subject experiences both an EAR and an LAR
•5.Methacholine PC20 (The provocation concentration of methacholine causing a 20% fall in FEV1) =16 mg/mL at Screening Visit 2.
•6.No history of smoking within 6 months of Screening Visit 1, and with a total pack year history of = 10 pack years.
•7.Be able to give written signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 22
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 22
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Past or present disease which, as judged by the Investigator, may affect the outcome of this study.
•2.Respiratory tract infection or exacerbation of asthma within 4 weeks prior to the first dose of study drug.
•3.Symptomatic allergic rhinitis.
•4.History of life-threatening asthma.
•5.Administration of systemic glucocorticosteroid therapy steroids within 6 weeks or topical or inhaled steroids within 1 month of Screening Visit 1.
•6.Positive drug or alcohol result at Screening Visit 1 or on Day 1 of either treatment period. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
•7.Subject has recently participated in a clinical trial and have received an investigational product
•8.Subject is pregnant, planning to conceive or lactating.
•9.History of being unable to tolerate or complete methacholine or allergen challenge tests.
•10.Subjects, who, on more than 2 occasions, after 2 concurrent administrations of saline during the allergen challenge at screening, had a fall in FEV1 of greater than 10%.
•11.Subject is undergoing allergen desensitisation therapy. History of immunotherapy in the 3 years prior to Screening Visit 1 or concurrently undergoing immunotherapy treatment.

发起方

AQUINOX PHARMACEUTICALS INC