Respiratory muscle training with steam inhalation clinical trial begins in Finland
Photo by Eli DeFaria
The research company WellO2 Oy is conducting the clinical trial Effects of Combined Respiratory Muscle Training and Steam Inhalation.
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.
It is planned to include 60 participants.
Actual study start date is August 1, 2020. The researchers expect to complete the study by March 30, 2021.
One primary outcome measure is 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.
Inclusion Criteria: 1. Age 18-65 years 2. Ethnic origin: Finnish 3. Both men and women are included 4. Diagnosed COPD or asthma or both 5. The duration of the illness at least 1 year, and the disease is at a stable stage 6. Pulmonary medication: unchanged for 4 weeks before the start of the study and throughout the study and some other.
Exclusion Criteria: 1. Previous history of pneumothorax 2. Unstable emphysema 3. Chest, abdominal, or cerebral aneurysms 4. Epilepsy 5. Chronic nose bleeding 6. Recent (< 3 months) surgical operations 7. Pregnancy 8. Unstable mental health issues 9. Alcohol consumption more than 10 portions/week (one portion is e.g. 4 cl of strong drinks including 40 % alcohol by volume) and some other.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04584398) Tampere, Finland.
