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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Medical Center Johanneksen Klinikka

    Tampere, 33210

    Jukka Heinijoki, MD, +358(0)400 666676, jukka.heinijoki@johanneksenklinikka.fi

    Recruiting

Other trials in Finland

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.

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 groups in NCT04584398
Study groupRoleWhat they receive
InterventionExperimentalThe 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
ControlNo interventionThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted14 Oct 2020
  2. Study start1 Aug 2020
  3. Primary completion2 Mar 2021 (estimated)
  4. Study completion30 Mar 2021 (estimated)

Resources

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)
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

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.

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