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Effects of Combined Respiratory Muscle Training and Steam Inhalation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584398
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Oy Medfiles
Information provided by (Responsible Party):
WellO2 Oy

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.

Condition or disease Intervention/treatment Phase
Airway Obstruction Asthma COPD Device: Respiratory muscle training with steam inhalation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, single-blind parallel design with 50-60 subjects suffering from obstructive diseases such as asthma or COPD or both.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The study is conducted as a randomized, single-blind (for evaluators), controlled, 30 days intervention trial with two parallel groups
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : March 2, 2021
Estimated Study Completion Date : March 30, 2021

Arm Intervention/treatment
Experimental: Intervention
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
No Intervention: Control
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.



Primary Outcome Measures :
  1. Change in forced expiratory volume in one second (FEV1) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference of FEV1 between and within the arms compared to the baseline


Secondary Outcome Measures :
  1. Change in vital capacity (VC) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  2. Change in forced vital capacity (FVC) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  3. Change in peak expiratory flow (PEF) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  4. Change in forced expiratory volume in one second / vital capacity (FEV1/VC) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  5. Change in forced expiratory volume in one second / forced vital capacity (FEV1/FVC) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  6. Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  7. Change in maximal mid-expiratory flow (MMEF) measured with spirometry [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  8. Bronchodilatation test with inhaled salbutamol (0,4 mg) [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  9. Change in arterial oxygen saturation SpO2 (%) [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  10. Change in maximal expiratory and inspiratory airway pressures (MEP and MIP) [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  11. Change in systolic and diastolic blood pressure at rest [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline

  12. Change in heart rate at rest [ Time Frame: 30 days intervention plus 190 days washout period ]
    Statistical difference between and within the arms compared to the baseline


Other Outcome Measures:
  1. Adverse events [ Time Frame: 120 days ]
    Total number and severity of adverse events between the test and control group during the intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584398


Contacts
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Contact: Ilpo Kuronen, PhD +358(0)451393757 ilpo.kuronen@wello2.com
Contact: Katri Lindberg +358 (0)407373712 katri.lindberg@wello2.com

Locations
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Finland
Medical Center Johanneksen Klinikka Recruiting
Tampere, Finland, 33210
Contact: Jukka Heinijoki, MD    +358(0)400 666676    jukka.heinijoki@johanneksenklinikka.fi   
Sponsors and Collaborators
WellO2 Oy
Oy Medfiles
Investigators
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Principal Investigator: Jukka Heinijoki, MD Medical center Johanneksen Klinikka
Additional Information:
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Responsible Party: WellO2 Oy
ClinicalTrials.gov Identifier: NCT04584398    
Other Study ID Numbers: HA010
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by WellO2 Oy:
Respiration
Respiratory muscle training
Steam inhalation
Additional relevant MeSH terms:
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Respiratory Aspiration
Airway Obstruction
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Respiratory Insufficiency