Clinical trial NCT04584398: Effects of Combined Respiratory Muscle Training and Steam Inhalation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Obstruction
Asthma
COPD
Keywords: Respiration
Respiratory muscle training
Steam inhalation
Lead sponsor: WellO2 Oy
Sponsor class: INDUSTRY
Collaborators: name: Oy Medfiles
First posted: 2020-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, single-blind parallel design with 50-60 subjects suffering from obstructive diseases such as asthma or COPD or both.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent
2. Age 18-65 years
3. Ethnic origin: Finnish
4. Both men and women are included
5. Diagnosed COPD or asthma or both
6. The duration of the illness at least 1 year, and the disease is at a stable stage
7. Pulmonary medication: unchanged for 4 weeks before the start of the study and throughout the study
8. Severity of the disease: mild, moderate or severe
9. The baseline FEV1 45-90 % of predicted normal value (Kainu et al 2016)
10. Eventual previous smoking has been ceased at least four weeks before the study
11. Compliance and commitment to the study (volunteered study subjects)

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)
10. Drug addiction
11. Non-compliance to the study protocol
12. History of worsening asthma symptoms at sauna
13. Any other pulmonary disease than asthma or COPD
14. Any other major illnesses such as heart failure, coronary artery disease, neurological diseases or type 1 diabetes
15. Smoking during the study period of 16 weeks

Primary outcomes:
measure: Change in forced expiratory volume in one second (FEV1) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
Secondary outcomes:
measure: Change in vital capacity (VC) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in forced vital capacity (FVC) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in peak expiratory flow (PEF) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in forced expiratory volume in one second / vital capacity (FEV1/VC) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in forced expiratory volume in one second / forced vital capacity (FEV1/FVC) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in maximal mid-expiratory flow (MMEF) measured with spirometry
timeFrame: 30 days intervention plus 190 days washout period
measure: Bronchodilatation test with inhaled salbutamol (0,4 mg)
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in arterial oxygen saturation SpO2 (%)
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in maximal expiratory and inspiratory airway pressures (MEP and MIP)
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in systolic and diastolic blood pressure at rest
timeFrame: 30 days intervention plus 190 days washout period
measure: Change in heart rate at rest
timeFrame: 30 days intervention plus 190 days washout period
Other outcomes:
measure: Adverse events
timeFrame: 120 days
Locations:
city: Tampere
country: Finland
facility: Medical Center Johanneksen Klinikka
Study officials:
affiliation: Medical center Johanneksen Klinikka
name: Jukka Heinijoki, MD
role: PRINCIPAL_INVESTIGATOR
References: