A Phase III, randomised, double-blind, double-dummy cross-over study to compare two dry powder inhaled formulations of budesonide on methacholine hyper-reactivity in patients with stable, persistent, moderate asthma.

eolab Limited0 个研究点目标入组 30 人开始时间: 2005年12月12日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1. Written informed consent given by patient.
•2. Male or female patients between 18 and 65 years of age inclusive.
•3. Inhaled corticosteroid (ICS) naïve or taking = 800 µg beclomethasone dipropionate (BDP) per day, or equivalent
•4. Symptomatic patients suffering from stable, persistent, moderate asthma as defined by GINA Guidelines and for whom FEV1 is = 60% and =80% of that predicted by European Community for Coal and Steel. (Confirmation of the criteria will be made at randomisation.)
•5. Willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD) (women of childbearing potential only).
•6. In the opinion of the investigator, able and willing to comply with the requirements of the protocol.
•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 BUD or any other constituents of the Test or Reference DPI
•2. 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.
•3. Females who are pregnant, lactating or planning to become pregnant.
•4. Currently not a smoker or who has ceased smoking at least 6 months previously.
•5. Clinically significant laboratory value, as judged by the investigator.
•6. Patients who have previously been enrolled into this study.
•7. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
•8. Patients who are scheduled to receive any other investigational drug during the course of the study.
•9. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.

发起方

eolab Limited