Effect of Respiratory Training and Steam Inhalation With WellO2 Device on Lung Function and Respiratory Symptoms in Patients With Chronic Obstructive Lung Diseases - a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- WellO2 Oy
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in forced expiratory volume in one second (FEV1) measured with spirometry
研究概览
简要总结
The purpose of this investigation is to obtain more information on the efficacy and safety of respiratory training methods with WellO2 in patients with asthma and COPD. Such a training may offer an additional, non-pharmacological way for treatment and therapy of asthma and COPD.
详细描述
Numerous respiratory muscle training (RMT) experiments with healthy subjects, as well as with patients of chronic obstructive pulmonary disease (COPD), bronchiectasis and asthma, have been reported since 80's. Respiratory training with WellO2 device was used in a clinical pilot study by Huttunen and Rantala to investigate effects of steam inhalation and RMT on voice quality in patients with voice symptoms. No adverse effects were found in that study.
The present study is designed to investigate further the RMT and steam inhalation on lung function and respiratory symptoms with subjects suffering from obstructive diseases such as asthma and COPD. The results may be used later in statistical power calculations and to determine the endpoints of larger clinical trial with the investigational device.
Asthma is still an increasing problem in many countries, even though, incidence of the most severe asthma cases is in decline due to earlier diagnosis, better control and earlier intervention practices. The prevalence of asthma and COPD in western countries is around 10 % and 5 %, respectively. The prevalence of COPD is higher in the countries where smoking and poor quality of inhaled air are common.
The treatment of asthma is based on treatment of eosinophilic inflammation of the airways by inhaled corticosteroids and on treatment of bronchoconstriction by sympathomimetic bronchodilators, short-acting and long-acting. The drugs may, however, induce side effects like voice disorders and cardiac symptoms (palpitation, tachycardia and extrasystoles).
Therefore, in many cases the doses of the drugs cannot continuously be kept at the highest effective level. Therefore, non-pharmacological methods can complement the treatment portfolio. The breathing physiotherapy by respiratory muscle training and warm steam inhalation can offer an additive treatment method for patients with airway obstruction.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The study is conducted as a randomized, single-blind (for evaluators), controlled, 30 days intervention trial with two parallel groups
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Age 18-65 years
- •Ethnic origin: Finnish
- •Both men and women are included
- •Diagnosed COPD or asthma or both
- •The duration of the illness at least 1 year, and the disease is at a stable stage
- •Pulmonary medication: unchanged for 4 weeks before the start of the study and throughout the study
- •Severity of the disease: mild, moderate or severe
- •The baseline FEV1 45-90 % of predicted normal value (Kainu et al 2016)
- •Eventual previous smoking has been ceased at least four weeks before the study
- •Compliance and commitment to the study (volunteered study subjects)
排除标准
- •Previous history of pneumothorax
- •Unstable emphysema
- •Chest, abdominal, or cerebral aneurysms
- •Chronic nose bleeding
- •Recent (< 3 months) surgical operations
- •Unstable mental health issues
- •Alcohol consumption more than 10 portions/week (one portion is e.g. 4 cl of strong drinks including 40 % alcohol by volume)
- •Drug addiction
- •Non-compliance to the study protocol
- •History of worsening asthma symptoms at sauna
- •Any other pulmonary disease than asthma or COPD
- •Any other major illnesses such as heart failure, coronary artery disease, neurological diseases or type 1 diabetes
- •Smoking during the study period of 16 weeks
结局指标
主要结局
Change in forced expiratory volume in one second (FEV1) measured with spirometry
时间窗: 30 days intervention plus 190 days washout period
Statistical difference of FEV1 between and within the arms compared to the baseline
次要结局
- Bronchodilatation test with inhaled salbutamol (0,4 mg)(30 days intervention plus 190 days washout period)
- Change in forced expiratory volume in one second / vital capacity (FEV1/VC) measured with spirometry(30 days intervention plus 190 days washout period)
- Change in forced expiratory volume in one second / forced vital capacity (FEV1/FVC) measured with spirometry(30 days intervention plus 190 days washout period)
- Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry(30 days intervention plus 190 days washout period)
- Change in maximal expiratory and inspiratory airway pressures (MEP and MIP)(30 days intervention plus 190 days washout period)
- Change in systolic and diastolic blood pressure at rest(30 days intervention plus 190 days washout period)
- Change in vital capacity (VC) measured with spirometry(30 days intervention plus 190 days washout period)
- Change in forced vital capacity (FVC) measured with spirometry(30 days intervention plus 190 days washout period)
- Change in maximal mid-expiratory flow (MMEF) measured with spirometry(30 days intervention plus 190 days washout period)
- Change in arterial oxygen saturation SpO2 (%)(30 days intervention plus 190 days washout period)
- Change in heart rate at rest(30 days intervention plus 190 days washout period)
- Change in peak expiratory flow (PEF) measured with spirometry(30 days intervention plus 190 days washout period)