Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in trough R5 from baseline after chronic dosing
研究概览
简要总结
In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients.
In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being
排除标准
- •Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis
- •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 investigational medicinal product
- •Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
- •Pregnancy or lactation
- •Unable to comply with the procedures of the protocol
研究组 & 干预措施
Tiotropium
Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.
干预措施: Tiotropium (Drug)
Aclidinium
Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.
干预措施: Aclidinium (Drug)
结局指标
主要结局
Change in trough R5 from baseline after chronic dosing
时间窗: 4 to 6 weeks
次要结局
- Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)(4 to 6 weeks)
- Spirometry (FEV1, FEF25-75, FVC)(4 to 6 weeks)
- Relaxed VC (RVC) with RVC to FVC ratio(4 to 6 weeks)
- Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)(4 to 6 weeks)
- Domiciliary PIKO-6 measurements for FEV1 and FEV6(4 to 6 weeks)
- St. George's Respiratory Questionnaire (SGRQ)(4 to 6 weeks)
- Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)(4 to 6 weeks)
研究者
Brian J Lipworth
Professor of Allergy and Pulmonology
University of Dundee