An interventional study of Thermotherapy/sauna bath in Lung Diseases, Obstructive, Bronchiectasis and Asthma, sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Not applicable, Interventional, and Treatment
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.
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.
202 studies on the registry are indexed under Lung Diseases, Obstructive; 22 are open to participants now.
This study's planned enrollment of 150 is above the median of 112 across 123 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Chronic Obstructive Pulmonary Disease Trial Network, Denmark is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Thermotherapy/sauna bath
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.
Thermotherapy/sauna bath
Number of days from baseline without antibiotic treatment against pulmonary infection
This is a measure of infectious exacerbations.
Time frame: 6 months
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.
Absence of bacteria, which lead to inclusion, is measured by a min. of 3 consecutive expectorates with a min. of 24 hours in between.
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2032, 72 months after the start.
Of 28 interventional studies with no phase under Lung Diseases, Obstructive, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 72 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Dec 2029 → Oct 2032 and completion Dec 2029 → Oct 2032.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Chronic Obstructive Pulmonary Disease Trial Network, Denmark