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.
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
- 14 Oct 2026to 31 Oct 2032
- 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.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte University hospital
Hellerup, Capital Region, 2900
josefin V Eklöf, MD, 38673555 ext. +45, josefin.viktoria.ekloef@regionh.dk
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.
- Conditions
- Lung Diseases, Obstructive, Bronchiectasis, Asthma, Copd, Chronic Obstructive Pulmonary Disease, 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 group | Role | What they receive |
|---|---|---|
| Thermotherapy/sauna bath | Experimental | Must 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 bath | No intervention | Not 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.
Number of days from baseline without antibiotic treatment against pulmonary infection
This is a measure of infectious exacerbations.
Measured: 6 months
Secondary outcomes (8)
Number of hospitalizations for all causes or death within 6 months
Measured: 6 months
Changes in antibiotic usage
Measured: 6 months
Number of antibiotic treatment regimes within 6 months
Measured: 6 months
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
Physical performance measured by distance walked over 6 minutes
Measured: 6 months
Changes in FEV1 after 6 months
Measured: 6 months
Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months
Measured: 6 months
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.
- First posted28 Apr 2022
- Study start14 Oct 2026
- Primary completion31 Oct 2032 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, ObstructiveStudies 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermotherapy Against Persistent Bacterial LUNG Infections
- ClinicalTrials.gov ID
- NCT05351242
- Acronym / sponsor ID
- THERMA-LUNG / THERMA-LUNG 2.0
- Conditions
- Lung Diseases, Obstructive, Bronchiectasis, Asthma, Copd, Chronic Obstructive Pulmonary Disease, Chronic Lung Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, DenmarkUniversity, hospital or other
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 28 Apr 2022 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermotherapy/sauna bath | Experimental | Other: Thermotherapy/sauna bathMust 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 |
| No thermotherapy/sauna bath | No intervention | –Not 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Thermotherapy/sauna bathThermotherapy/sauna bath | Other | Thermotherapy/sauna bath |
Primary outcome
Number of days from baseline without antibiotic treatment against pulmonary infection
Time frame: 6 months
This is a measure of infectious exacerbations.
8 secondary outcomes
Number of hospitalizations for all causes or death within 6 months
Time frame: 6 months
Changes in antibiotic usage
Time frame: 6 months
Number of antibiotic treatment regimes within 6 months
Time frame: 6 months
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.
Time frame: 6 months
Physical performance measured by distance walked over 6 minutes
Time frame: 6 months
Changes in FEV1 after 6 months
Time frame: 6 months
Clinically relevant changes in Chronic Obstructive Pulmonary Disease Assessment Test-score (range from 0-40, higher is worse) after 6 months
Time frame: 6 months
Changes in status from Medical Research Council-dyspnea score (range from 0-5, higher is worse) from <3 to 3≥, after 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
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: looking for participants now, as of the sponsor's last update on 6 Nov 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?
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 6 Nov 2026.