An interventional study of Respiratory muscle training with steam inhalation in Airway Obstruction, Asthma and COPD, sponsored by WellO2 Oy. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by WellO2 Oy · Not applicable, Interventional, and Treatment
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.
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.
It is possible that training with the combination of positive counter pressure and steam inhalation methods can induce significant improvement in ventilatory function variables and respiratory symptoms in asthmatics who have kept their ordinary pharmacological therapy at a constant level. Based on the previous scientific evidence found on the public domains, it can be expected that the respiratory muscle strength will be increased offering a possibility for more effective pulmonary mechanics, ventilation and lung volumes. In addition, exhaling against resistance will induce a positive end expiratory pressure (PEEP) effect which can open narrowed airways and make the distribution of alveolar ventilation less heterogeneous. This can improve gas exchange in the lungs and increase the level of low oxygen saturation in arterial blood.
In COPD, drugs can improve the airway changes, irreversible thickening of the airway walls, and chronic inflammation only partially. Therefore, breathing physiotherapy may offer an additive method to improve lung function and gas exchange, and to diminish dyspnoea and other symptoms like cough. The mechanisms of RMT are principally the same in asthma and COPD. Patients with obstructive airway disease frequently have both COPD and asthma, partly reversible or irreversible.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's planned enrollment of 60 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →This is the only study on the registry with WellO2 Oy as lead sponsor.
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Exclusion Criteria:
The intervention group (A) will perform respiratory muscle training and steam inhalation with WellO2 device for 30 days.
Device: Respiratory muscle training with steam inhalation
The control group (B) will continue on their conventional treatment without respiratory muscle training or steam inhalation with WellO2. After 30 days, the group B performs the same 30-day intervention with the WellO2 device (test) as the group A.
Change in forced expiratory volume in one second (FEV1) measured with spirometry
Statistical difference of FEV1 between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in vital capacity (VC) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in forced vital capacity (FVC) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in peak expiratory flow (PEF) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in forced expiratory volume in one second / vital capacity (FEV1/VC) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in forced expiratory volume in one second / forced vital capacity (FEV1/FVC) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in maximal mid-expiratory flow (MMEF) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Bronchodilatation test with inhaled salbutamol (0,4 mg)
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in arterial oxygen saturation SpO2 (%)
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in maximal expiratory and inspiratory airway pressures (MEP and MIP)
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in systolic and diastolic blood pressure at rest
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Change in heart rate at rest
Statistical difference between and within the arms compared to the baseline
Time frame: 30 days intervention plus 190 days washout period
Adverse events
Total number and severity of adverse events between the test and control group during the intervention
Time frame: 120 days
Plan to share: No
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