An interventional study of Vibroacoustic device and Standard induced sputum collection in COPD (Chronic Obstructive Pulmonary Disease), sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine. Recruiting at 1 site in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine · Not applicable, Interventional, and Basic science
Induced sputum is a non-invasive method to collect samples from the airways. It involves inhaling a saline mist to loosen mucus, which is then coughed up. The samples are used to study markers of lung disease. In some people, this procedure yields only small amounts of sample.
This study looks at whether adding a vibroacoustic device during sputum induction can increase the amount of sputum collected in patients with chronic obstructive pulmonary disease (COPD). The device applies gentle sound-based vibrations to the chest to help move mucus in the airways.
Each participant undergoes two sputum collection procedures on separate days:
one with and one without the device. The order is assigned at random. The main comparison is the amount of sputum obtained with versus without the device in the same person. The study also assesses how well the procedure is tolerated.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 20 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Fraunhofer-Institute of Toxicology and Experimental Medicine is the lead sponsor of 38 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 8, 2026. See what changed
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:
Any condition that, as judged by the investigator, constitutes a or safety concern for the application of vibroacoustic chest therapy. This includes, but is not limited to:
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sputum induction with adjunctive use of the vibroacoustic device at the first visit, followed by standard sputum induction without the device at the second visit (at least 14 days later).
Device: Vibroacoustic device · Procedure: Standard induced sputum collection
Standard sputum induction without the device at the first visit, followed by sputum induction with adjunctive use of the vibroacoustic device at the second visit (at least 14 days later).
Device: Vibroacoustic device · Procedure: Standard induced sputum collection
A CE-marked vibroacoustic device is applied to the chest wall during sputum induction. It generates frequency-modulated acoustic waves transmitted through the chest to help mobilize airway secretions.
Sputum induction performed according to ATS/ERS recommendations: inhalation of nebulized saline to stimulate airway secretions, followed by directed coughing to expectorate sputum. Performed without the vibroacoustic device.
Within-subject difference in weight of selected sputum plugs (with vs. without device)
Weight in grams of selected sputum plugs obtained by induced sputum collection, determined by gravimetry. The primary analysis is the within-subject difference in sputum plug weight between the procedure performed with adjunctive use of the vibroacoustic device and the procedure performed without the device.
Time frame: At each of the two sputum induction visits (Visit 1 and Visit 2, approximately 14 to 21 days apart)
Within-subject difference in procedural discomfort rating (with vs. without device)
Overall procedural discomfort assessed immediately after each sputum induction procedure using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no discomfort) to 10 (worst imaginable discomfort); higher scores indicate greater discomfort (worse outcome). The within-subject difference in scores between the device and non-device conditions is used to assess device-related procedural burden.
Time frame: Immediately after each sputum induction procedure at Visit 1 and Visit 2
Proportion of participants willing to undergo the device-assisted procedure again
Device acceptability, measured as the proportion of participants who report they would be willing to undergo the device-assisted sputum induction procedure again (yes/no), recorded at the visit at which the device was applied.
Time frame: At the device-assisted procedure (Day 1 or Day 14, up to Day 21)
Proportion of participants completing all device-assisted inhalation periods
Device completion rate, defined as the proportion of participants who complete all device-assisted inhalation periods without premature discontinuation of the device and without reduction to single-emitter application.
Time frame: At the device-assisted procedure (Day 1 or Day 14, up to Day 21)
Incidence, nature, and severity of procedure-related adverse events
Adverse events recorded at each visit, including onset, duration, intensity, and causal relationship to study procedures. The crossover design allows comparison of adverse event profiles between the device and non-device conditions.
Time frame: From Visit 1 through end of study (up to approximately 21 days)
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 4 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
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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Pulmonary Disease, Chronic Obstructive →
Fraunhofer-Institute of Toxicology and Experimental Medicine