Tiotropium Respimat Soft Mist Inhaler Versus HandiHaler to Improve Sleeping Oxygen Saturation and Sleep Quality in COPD.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Sleep Quality
研究概览
简要总结
The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.
详细描述
Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension >60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged >=40 years old
- •current or ex-smokers with a smoking history of at least 10 pack-years
- •mild to moderate stable COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] Stage I and II according to the 2010 GOLD guidelines (a post-bronchodilator forced expiratory volume in the first second (FEV1) ≥80% of predicted for stage I and 50% ≤ FEV1 < 80% of predicted for stage II, with a post-bronchodilator FEV1/forced vital capacity (FVC) ratio <0.70 at screening)
- •waking arterial oxygen tension (PaO2) ≥60 mmHg
排除标准
- •refusal to participate
- •respiratory tract infection within 4 weeks prior to screening
- •COPD exacerbations requiring treatment with antibiotics and/or oral corticosteroids and/or hospitalization within 6 weeks prior to screening
- •concomitant pulmonary diseases other than COPD
- •evidence of sleep apnea on baseline sleep studies
- •obesity hypoventilation syndrome
- •respiratory failure
- •congestive heart failure
- •a history of life-threatening arrhythmias
- •cardiomyopathy
- •long-QT syndrome or QTc >450 ms at screening
- •long-term oxygen therapy
- •symptomatic prostatic hyperplasia
- •bladder-neck obstruction
- •moderate/severe renal impairment
- •urinary retention
- •narrow-angle glaucoma
- •family or personal history of mental illness
- •drug or alcohol abuse
- •severe cognitive impairment
- •concurrent oncological diseases
- •history of narcolepsy or restless legs syndrome
- •known history of alpha-1 antitrypsin deficiency
- •participation in the active phase of a supervised pulmonary rehabilitation program
- •hypersensitivity to any of the test ingredients
- •history of adverse reactions to inhaled anticholinergics.
研究组 & 干预措施
Handihaler
Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
干预措施: tiotropium (Drug)
Handihaler
Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler
干预措施: Handihaler (Device)
Respimat
Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
干预措施: tiotropium (Drug)
Respimat
Tiotropium was delivered via the Respimat® Soft Mist Inhaler,
干预措施: Respimat (Device)
结局指标
主要结局
Sleep Quality
时间窗: 6 months after treatment initiation
Sleep quality, meaning the architecture of sleep (amount of the different sleep stages across the sleep episode),consists of sleep efficiency (%) (total sleep time - TST divided by the total time in bed and multiplied by 100), REM (%TST) (rapid eye movement sleep divided by TST and multiplied by 100) and NREM (%TST) (non-rapid eye movement sleep divided by TST and multiplied by 100). NORMAL RANGES Sleep efficiency: Normal is approximately 85 to 90% or higher. NREM (%TST): 75-80% REM (%TST) normally occupies about 20-25% of sleep time.
Sleeping Oxygen Saturation
时间窗: 6 months after treatment initiation
Mean sleeping oxygen saturation (%)
次要结局
- Sleepiness(6 months after treatment initiation)
- Hospitalization Rate(6 months after treatment initiation)
研究者
Izolde Bouloukaki
Consultant
University of Crete