Proof of Concept Evaluation of Drug-Device Interaction with aclidinium bromide via Genuair® and tiotropium bromide via HandiHaler® in COPD using Impulse Oscillometry - MAN04 Evaluation of Long-Acting Muscarinic Antagonists in COPD

Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside0 个研究点目标入组 14 人开始时间: 2013年12月3日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3).
•On inhaled corticosteroids / long-acting beta agonists
•FEV1 30-80% predicted and FEV1/FVC <70%.
•Smoking history =10 pack-years.
•Ability to give informed consent
•Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•Other respiratory diseases such as asthma, bronchiectasis or ABPA
•A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required)
•Any clinically significant medical condition that may endanger the health or safety of the participant
•Known or suspected sensitivity to/intolerance of IMP
•Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
•Pregnancy or lactation
•Unable to comply with the procedures of the protocol

发起方

Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside