Description of the Ability to Learn How to Handle Inhaler Devices in COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the world and further increase in its prevalence and mortality has been predicted. Currently, the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:
- long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),
- long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).
These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.
详细描述
The correct use of inhaler devices is an inclusion criterion in COPD clinical trials. In real life, patients may make many errors using their own inhaler device, which may alter the positive effects observed in clinical trials.
The main objective of this study is to describe the handling of inhaler devices (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) in patients with COPD.
All participants will receive each of the three treatments (Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg and Spiriva® Respimat® 2,5 μg). Each treatment will be given daily for one week, followed by a 7-day washout period.
On day 1 of each treatment period, the patient will have clinical examination, lung function testing (FEV1) and 2 video recordings:
- Video recording #1: inhalation (one puff) without any instruction of use,
- Video recording #2: inhalation (one puff) after reading the patient information leaflet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged more than 40 years,
- •Written informed consent,
- •Diagnosis of COPD according to international guidelines (GOLD 2012),
- •Social security or health insurance,
- •Women of childbearing potential with a very effective contraception according to the Haute Autorité de Santé (HAS) recommendations.
排除标准
- •Previous treatment with Breezhaler®, Diskus® or Respimat® or similar device,
- •QT ≥ 450 ms,
- •Contraindications to tiotropium: hypersensitivity to tiotropium,
- •Contraindications to indacatérol: hypersensitivity to indacatérol,
- •Contraindications to salmeterol: hypersensitivity to salmeterol,
- •Contraindications to fluticasone: hypersensitivity to fluticasone,
- •Contraindications to glycopyrronium: hypersensitivity to glycopyrronium,
- •COPD exacerbation within 6 weeks before inclusion,
- •Chronic psychiatric disease,
- •Medical condition that may affect handling of inhaler devices,
- •Subject deprived of his/her liberty,
- •Protected adult,
- •Subject in exclusion period related to another protocol,
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Group 1
干预措施: Seretide® Diskus® 500/550 μg (Drug)
Group 2
干预措施: Seretide® Diskus® 500/550 μg (Drug)
Group 3
干预措施: Seretide® Diskus® 500/550 μg (Drug)
Group 1
干预措施: Ultibro® Breezhaler® 110/50 μg (Drug)
Group 2
干预措施: Ultibro® Breezhaler® 110/50 μg (Drug)
Group 3
干预措施: Spiriva® Respimat® 2,5 μg (Drug)
Group 1
干预措施: Spiriva® Respimat® 2,5 μg (Drug)
Group 2
干预措施: Spiriva® Respimat® 2,5 μg (Drug)
Group 3
干预措施: Ultibro® Breezhaler® 110/50 μg (Drug)
结局指标
主要结局
Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist
时间窗: Day 7 of each treatment
次要结局
- Number of non device-dependant errors from standardized checklist(Day 7 of each treatment)
- Number of non critical errors from standardized checklist(Day 7 of each treatment)
- Measure of the time necessary for drug administration(Up to day 7 of each treatment)
- Measure of Forced Expiratory Volume in 1 second (FEV1)(At baseline and at day 7)
- Collection of adverse events(Up to day 66)