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Lung Diseases, ObstructiveTHERMA-LUNGNCT05351242

THERMotherapy Against Persistent Bacterial LUNG Infections

A study testing Thermotherapy/sauna bath in people with Lung Diseases, Obstructive and Bronchiectasis, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Diseases, Obstructive, Bronchiectasis, Asthma
What is being tested?
Thermotherapy/sauna bath
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteDenmark
Study dates
1 Oct 2026to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Competent and capable
  • FEV1>1,0 L
  • Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics
  • Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months

Who cannot join

  • Allergy to lidocaine and/or midazolam
  • Contraindications to bronchoscopy
  • Previous severe laryngospasm (intubation requiring)
  • Pregnancy/breastfeeding
  • Severe linguistic problems or inability to give informed consent
  • Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Josefin V Eklöf, MD contact

38673555 ext. +45

josefin.viktoria.ekloef@regionh.dk

Jens-Ulrik S Jensen, Professor contact

38673057 ext. +45

jens.ulrik.jensen@regionh.dk

Denmark1 site

  • Herlev and Gentofte University hospital

    Hellerup, Capital Region, 2900

    josefin V Eklöf, MD, 38673555 ext. +45, josefin.viktoria.ekloef@regionh.dk

Other trials in Denmark

About this study

Official title: Thermotherapy Against Persistent Bacterial LUNG Infections

The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.

Read the detailed description

Normally, bacterial lung infections are acute such as community-acquired pneumonia and typically resolve after antibiotic therapy without leaving much lasting damage on the lungs. However, a great amount of persons with disrupted clearance of mucus and/or lung immune system get persistent lung infections, which can be life-long, usually do not resolve even with antibiotics, and can greatly increase morbidity and mortality. IThese persistent lung infections are thus characterized by stable periods with exacerbations inbetween, akin to chronic lung diseases such as asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. In addition, it has not been thoroughly investigated whether antibiotic regimens have an effect on disease control, as biofilm formation prevents antibiotics from killing the bacteria.

This is a randomized, controlled, multi-center, superiority trial evaluating the effect of a thermotherapy intervention, consisting of min. 7 minutes stay in min. 85℃ environment at least 4 times a week for 6 months, in persons with persistent bacterial lung infection, defined as min. 2 positive cultures during the last 24 months for one of the following bacteria: Pseudomonas aeruginosa, Achromobacter xylosoxidans, Stenotrophomonas maltophilia, Klebsiella oxytoca, Klebsiella pneumoniae, Haemophilus influenzae or Staphylococcus aureus, incl. 1 positive culture after attempted eradication therapy. The aim of the study is to investigate whether thermotherapy may offer a valid proposal for treatment of chronic lung infections.

Being tested
Thermotherapy/sauna bath
Medical subject headings
Lung Diseases, Obstructive, Bronchiectasis, Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thermotherapy/sauna bathOther

    Thermotherapy/sauna bath

Study groups in NCT05351242
Study groupRoleWhat they receive
Thermotherapy/sauna bathExperimentalMust go to a sauna (min. Temperature 85℃) min. 4 times a week for 6 months. Each sauna bath must last at least 7 minutes. The intervention patients receive a subscription card for a sauna during the period. Patients will still receive pre-existing treatment
Receives: Other: Thermotherapy/sauna bath
No thermotherapy/sauna bathNo interventionNot allowed to go to a sauna for 6 months. Patients who come to do so, by e.g. an oversight, however, remain in the study, to avoid introducing bias. It will be registered as a "protocol violation", but the patient will be included in Intention To Treat analysis and modified Intention To Treat analysis. Patients will still receive pre-existing treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days from baseline without antibiotic treatment against pulmonary infection

    This is a measure of infectious exacerbations.

    Measured: 6 months

Secondary outcomes (8)

  1. Number of hospitalizations for all causes or death within 6 months

    Measured: 6 months

  2. Changes in antibiotic usage

    Measured: 6 months

  3. Number of antibiotic treatment regimes within 6 months

    Measured: 6 months

  4. Eradication of the cultured bacteria at baseline, defined by a) absence of the trial inclusion bacteria or b) the participant cannot expectorate dure to dry airways.

    Absence of bacteria, which lead to inclusion, is measured by a min. of 3 consecutive expectorates with a min. of 24 hours in between.

    Measured: 6 months

  5. Physical performance measured by distance walked over 6 minutes

    Measured: 6 months

  6. Changes in FEV1 after 6 months

    Measured: 6 months

  7. Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months

    Measured: 6 months

  8. Changes in status from Medical Research Council-dyspnea score (range from 0-5, higher is worse) from <3 to 3≥, after 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (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
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351242
Sponsor's protocol ID
THERMA-LUNG 2.0
Acronym
THERMA-LUNG
Status last verified
Jun 2026
First submitted
19 Apr 2022
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
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 Thermotherapy/sauna bath in people with Lung Diseases, Obstructive and Bronchiectasis, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.

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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Jun 2026. 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 Denmark. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Josefin V Eklöf, MD (38673555 ext. +45, josefin.viktoria.ekloef@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days from baseline without antibiotic treatment against pulmonary infection (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05351242.

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 17 Jun 2026.

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