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Effects of Combined Respiratory Muscle Training and Steam Inhalation

Primary Purpose

Airway Obstruction, Asthma, COPD

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Respiratory muscle training with steam inhalation
Sponsored by
WellO2 Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Obstruction focused on measuring Respiration, Respiratory muscle training, Steam inhalation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center Johanneksen KlinikkaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

The intervention group (A) will perform respiratory muscle training and steam inhalation with WellO2 device for 30 days.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in vital capacity (VC) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Change in forced vital capacity (FVC) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Change in peak expiratory flow (PEF) measured with spirometry
Statistical difference between and within the arms compared to the baseline
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
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
Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Change in maximal mid-expiratory flow (MMEF) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Bronchodilatation test with inhaled salbutamol (0,4 mg)
Statistical difference between and within the arms compared to the baseline
Change in arterial oxygen saturation SpO2 (%)
Statistical difference between and within the arms compared to the baseline
Change in maximal expiratory and inspiratory airway pressures (MEP and MIP)
Statistical difference between and within the arms compared to the baseline
Change in systolic and diastolic blood pressure at rest
Statistical difference between and within the arms compared to the baseline
Change in heart rate at rest
Statistical difference between and within the arms compared to the baseline

Full Information

First Posted
September 21, 2020
Last Updated
October 5, 2020
Sponsor
WellO2 Oy
Collaborators
Oy Medfiles
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1. Study Identification

Unique Protocol Identification Number
NCT04584398
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 2, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WellO2 Oy
Collaborators
Oy Medfiles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction, Asthma, COPD
Keywords
Respiration, Respiratory muscle training, Steam inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, single-blind parallel design with 50-60 subjects suffering from obstructive diseases such as asthma or COPD or both.
Masking
InvestigatorOutcomes Assessor
Masking Description
The study is conducted as a randomized, single-blind (for evaluators), controlled, 30 days intervention trial with two parallel groups
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group (A) will perform respiratory muscle training and steam inhalation with WellO2 device for 30 days.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Respiratory muscle training with steam inhalation
Primary Outcome Measure Information:
Title
Change in forced expiratory volume in one second (FEV1) measured with spirometry
Description
Statistical difference of FEV1 between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Secondary Outcome Measure Information:
Title
Change in vital capacity (VC) measured with spirometry
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in forced vital capacity (FVC) measured with spirometry
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in peak expiratory flow (PEF) measured with spirometry
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in forced expiratory volume in one second / vital capacity (FEV1/VC) measured with spirometry
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in forced expiratory volume in one second / forced vital capacity (FEV1/FVC) measured with spirometry
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in maximal mid-expiratory flow (MMEF) measured with spirometry
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Bronchodilatation test with inhaled salbutamol (0,4 mg)
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in arterial oxygen saturation SpO2 (%)
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in maximal expiratory and inspiratory airway pressures (MEP and MIP)
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in systolic and diastolic blood pressure at rest
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Title
Change in heart rate at rest
Description
Statistical difference between and within the arms compared to the baseline
Time Frame
30 days intervention plus 190 days washout period
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Total number and severity of adverse events between the test and control group during the intervention
Time Frame
120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Previous history of pneumothorax Unstable emphysema Chest, abdominal, or cerebral aneurysms Epilepsy Chronic nose bleeding Recent (< 3 months) surgical operations Pregnancy 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilpo Kuronen, PhD
Phone
+358(0)451393757
Email
ilpo.kuronen@wello2.com
First Name & Middle Initial & Last Name or Official Title & Degree
Katri Lindberg
Phone
+358 (0)407373712
Email
katri.lindberg@wello2.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jukka Heinijoki, MD
Organizational Affiliation
Medical center Johanneksen Klinikka
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Johanneksen Klinikka
City
Tampere
ZIP/Postal Code
33210
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jukka Heinijoki, MD
Phone
+358(0)400 666676
Email
jukka.heinijoki@johanneksenklinikka.fi

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.wello2.com
Description
Manufacturer's web address

Learn more about this trial

Effects of Combined Respiratory Muscle Training and Steam Inhalation

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