Airway ObstructionNCT04584398
Effects of Combined Respiratory Muscle Training and Steam Inhalation
A study testing Respiratory muscle training with steam inhalation in people with Airway Obstruction and Asthma, run by WellO2 Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Obstruction, Asthma, COPD
- What is being tested?
- Respiratory muscle training with steam inhalation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- Previous history of pneumothorax
- Unstable emphysema
- Chest, abdominal, or cerebral aneurysms
- Epilepsy
- Chronic nose bleeding
- Recent (< 3 months) surgical operations
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- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Medical Center Johanneksen Klinikka
Tampere, 33210
Jukka Heinijoki, MD, +358(0)400 666676, jukka.heinijoki@johanneksenklinikka.fi
About this study
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
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.
Read the 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.
- Conditions
- Airway Obstruction, Asthma, COPD
- Being tested
- Respiratory muscle training with steam inhalation
- Keywords
- Respiration, Respiratory muscle training, Steam inhalation
- Medical subject headings
- Airway Obstruction, Asthma, Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle training with steam inhalationDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group (A) will perform respiratory muscle training and steam inhalation with WellO2 device for 30 days. Receives: Device: Respiratory muscle training with steam inhalation |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days intervention plus 190 days washout period
Secondary outcomes (12)
Change in vital capacity (VC) measured with spirometry
Statistical difference between and within the arms compared to the baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days intervention plus 190 days washout period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Aug 2020
- Primary completion2 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WellO2 Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oy Medfiles
- Responsible party
- Sponsor
- Investigators
- Jukka Heinijoki, MD, Principal investigator, Medical center Johanneksen Klinikka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584398
- Sponsor's protocol ID
- HA010
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04584398
- Acronym / sponsor ID
- HA010
- Conditions
- Airway Obstruction, Asthma, COPD
- Keywords
- Respiration, Respiratory muscle training, Steam inhalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- WellO2 OyIndustry (pharma, biotech, devices)
- Collaborators
- Oy Medfiles
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 2 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, single-blind parallel design with 50-60 subjects suffering from obstructive diseases such as asthma or COPD or both.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Respiratory muscle training with steam inhalationThe intervention group (A) will perform respiratory muscle training and steam inhalation with WellO2 device for 30 days. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent
- Age 18-65 years
- Ethnic origin: Finnish
- Both men and women are included
- Diagnosed COPD or asthma or both
Key exclusion criteria (15 listed)
- Previous history of pneumothorax
- Unstable emphysema
- Chest, abdominal, or cerebral aneurysms
- Epilepsy
- Chronic nose bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory muscle training with steam inhalation | Device | Intervention |
Primary outcome
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
12 secondary outcomes
Change in vital capacity (VC) measured with spirometry
Time frame: 30 days intervention plus 190 days washout period
Change in forced vital capacity (FVC) measured with spirometry
Time frame: 30 days intervention plus 190 days washout period
Change in peak expiratory flow (PEF) measured with spirometry
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
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
Time frame: 30 days intervention plus 190 days washout period
Change in maximum expiratory flow at 50% of FVC (MEF50) measured with spirometry
Time frame: 30 days intervention plus 190 days washout period
Change in maximal mid-expiratory flow (MMEF) measured with spirometry
Time frame: 30 days intervention plus 190 days washout period
Bronchodilatation test with inhaled salbutamol (0,4 mg)
Time frame: 30 days intervention plus 190 days washout period
Change in arterial oxygen saturation SpO2 (%)
Time frame: 30 days intervention plus 190 days washout period
Change in maximal expiratory and inspiratory airway pressures (MEP and MIP)
Time frame: 30 days intervention plus 190 days washout period
Change in systolic and diastolic blood pressure at rest
Time frame: 30 days intervention plus 190 days washout period
Change in heart rate at rest
Time frame: 30 days intervention plus 190 days washout period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Manufacturer's web addressLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jukka Heinijoki, MD principal investigator
Medical center Johanneksen Klinikka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training with steam inhalation in people with Airway Obstruction and Asthma, run by WellO2 Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilpo Kuronen, PhD (+358(0)451393757, ilpo.kuronen@wello2.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forced expiratory volume in one second (FEV1) measured with spirometry (time frame: 30 days intervention plus 190 days washout period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.