A Phase 3, randomised, open-label, cross-over study to compare HFA vs CFC pMDI formulations of budesonide on methacholine hyper-reactivity in patients with stable, persistent, mild to moderate asthma

AstraZeneca AB0 个研究点目标入组 0 人开始时间: 2007年12月28日最近更新: 2019年11月25日

适应症

试验速览

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•1.Provision of signed written informed consent before any study-related procedure is initiated
•2.Male or female patients between 18 and 65 years of age inclusive.
•3.Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 > 60 %
•4.ICS taking = 1000 µg BDP per day, or equivalent
•5.Methacholine PC20 < 4 mg/mL
•6.Ability to inhale from pMDI according to given instructions, as judged by the investigator or study nurse.
•For inclusion in the study treatment period subjects must fulfil all of the following criteria:
•1.Methacholine PC20 < 4 mg/mL
•2.FEV1 at the end of the run-in period > 60% predicted
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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.Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
•2.Using any medication that may interfere with the results of the study.
•3.Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study.
•4.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator. Fertile women must show a negative pregnancy test at Visit 1.
•5.Currently a smoker or who has ceased smoking within 6 months of Visit 1.
•6.Any clinically relevant abnormal laboratory values, as judged by the investigator.
•7.Previous allocation of randomization code in this study, for details see also section 3.5 of study protocol
•8.Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
•9.Patients who are scheduled to receive any other investigational drug during the course of the study.
•10.Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
•11.Patients with Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis
•12.Involvement in the planning and conduct of the study (applies to both

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