A Randomised, Single Dose Exposure Study to Assess the Safety, Tolerability and Pharmacokinetics of Investigational Captisol-Enabled® Budesonide InhalationSolution (CBIS) Delivered via eFlow® Nebuliser and Conventional BudesonideInhalation Suspension (Pulmicort Respules®) Delivered via LC Plus® JetNebuliser in Children with Asthma

Verus Pharmaceuticals Inc0 个研究点目标入组 18 人开始时间: 2006年9月18日最近更新: 2017年8月21日

研究概览

暂无简介。

•1.Age 4 to 8 years, inclusive, at the Screening Visit.
•2.History of asthma for greater than 6 months prior to the Screening Visit as confirmed with clinical signs and symptoms. For the purposes of this study, asthma” is defined by the Global Initiative for Asthma in the GSAMP[7].
•3.For steroid-requiring subjects, the dose of inhaled steroid medication received prior to the Screening Visit must be equal to or less than 1000 mcg/day budesonide or beclomethasone dipropionate or 500 mcg/day fluticasone proprionate.
•4.Must otherwise be healthy as judged by general physical examination, medical history and routine clinical laboratory screening.
•5.For subjects on inhaled budesonide medication, they must be willing to discontinue or replace treatment with their budesonide-containing medications with alternative medication for at least 5 days prior to the Treatment Visit.
•6.Provide written informed consent (parent or legal guardian) and, as appropriate, subject assent.
•7.Willing and able to attend scheduled visits and complete the entire study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.History of life-threatening asthma. This category includes those paediatric subjects with a history of systemic corticosteroid treatment within 3 months of study entry, or near-fatal asthma requiring intubation or a hospitalisation or an Urgent Care Facility visit for asthma in the past year.
•2.Current evidence or history of any clinically significant disease or abnormality. Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
•3.History of concomitant lung disease.
•4.An upper or lower respiratory tract infection within 4 weeks prior to the Screening Visit.
•5.Current evidence of oral candidiasis.
•6.Current evidence or history of hypersensitivity or idiosyncratic reaction to inhaled budesonide or any medication.
•7.Receipt of an investigational drug within 30 days of the Screening Visit.

发起方

Verus Pharmaceuticals Inc