COPD (Chronic Obstructive Pulmonary Disease)NCT07751705
Induced Sputum Collection in COPD Patients With and Without a Vibroacoustic Device
A study testing Vibroacoustic device and Standard induced sputum collection in people with COPD (Chronic Obstructive Pulmonary Disease), run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Vibroacoustic device and Standard induced sputum collection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 18 Aug 2026to Dec 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent.
- Male and female participants, aged ≥40-70 years. Women of childbearing potential (i.e. not post-menopausal, defined as amenorrhoeic for at least 12 months, and without documented surgical sterilization such as hysterectomy, bilateral oophorectomy, or tubal ligation) must not be pregnant, as confirmed by a negative urine pregnancy test prior to each sputum induction procedure, and must not be breastfeeding.
- Diagnosis of COPD based on post-bronchodilator spirometry, defined as FEV1/FVC < 0.70, consistent with GOLD criteria.
- FEV1 ≥50% of predicted (post-bronchodilator).
- Body mass index between 18 and 38 kg/m2
- Subgroup "Current Smokers": current smoking with at least 15 cigarettes per day over the past 12 months and a cumulative smoking history of at least 10 pack-years, confirmed by a positive urine cotinine test at screening.
- Subgroup "Ex-smokers": no smoking for at least one year prior to screening and a cumulative smoking history of at least 10 pack-years, confirmed by a negative urine cotinine test at screening
Who cannot join
- Any clinically relevant disease or condition which, in the opinion of the investigator, may significantly compromise participant safety, affect study outcomes, or prevent adherence to the protocol. Explicitly excluded is cystic fibrosis or interstitial lung disease.
- Any condition that, as judged by the investigator, constitutes a contraindication or safety concern for the application of vibroacoustic chest therapy. This includes, but is not limited to:
- Any implanted or external electronic-mechanical device in the thoracic projection area (e.g. cardiac pacemaker, implantable cardioverter-defibrillator, cardiac assist devices, implantable drug delivery pumps, neurostimulators)
- Coronary heart disease with coronary stents or history of percutaneous coronary intervention or coronary artery bypass grafting
- Mechanical heart valve prosthesis
- Aortic stent graft or thoracic endovascular implant
Show all 22Show fewer
- Unstable angina pectoris or acute coronary syndrome within the past 6 months
- Clinically significant cardiac arrhythmia requiring treatment (e.g. uncontrolled atrial fibrillation, ventricular tachycardia)
- Known large pulmonary bullae (>1 cm) or history of spontaneous pneumothorax
- Unstable rib fractures or thoracic vertebral fractures
- Active haemoptysis or known high risk of pulmonary haemorrhage
- Therapeutic anticoagulation or known coagulation disorder with increased bleeding risk
- Active thoracic malignancy
- Thoracic surgery within the past 6 month
- Initiation or discontinuation of mucolytic or expectorant agents (e.g., N-acetylcysteine, ambroxol) within 14 days prior to Visit 1 or between study visits. Participants on stable chronic mucolytic therapy (unchanged regimen for at least 4 weeks prior to Visit 1) may be enrolled provided they maintain the same regimen throughout the study.
- Treatment with systemic corticosteroids or biological therapies within 6 months prior to screening
- Treatment with antibiotics within 2 months prior to screening
- Lower respiratory tract infection within 4 weeks prior to screening
- Upper respiratory tract infection within 2 weeks prior to screening
- History of drug or alcohol abuse within 12 months prior to screening
- Participation in a clinical trial involving an investigational medicinal product within 6 months prior to screening
- Any condition associated with an increased risk of non-compliance with study procedures (e.g. inability to hold the vibroacoustic emitters against the chest because of severe arthritis, neuromuscular disease, or other condition significantly limiting upper extremity function).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Department of Clinical Airway Research
Hanover, Lower Saxony, 30625
Philipp Badorrek, MD, +49 511 5350-8103, philipp.badorrek@item.fraunhofer.de
Philipp Badorrek, MD
About this study
Official title: Randomized Crossover Study of Induced Sputum Collection in COPD Patients for Assay Development With and Without a Vibroacoustic Device
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.
Read more
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.
- Being tested
- Vibroacoustic device, Standard induced sputum collection
- Keywords
- Chronic Obstructive Pulmonary Disease, Induced Sputum, Sputum Induction, Airway Sampling, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibroacoustic deviceDevice
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.
Standard induced sputum collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibroacoustic Device First, Then Standard | Experimental | 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). Receives: Device: Vibroacoustic device; Procedure: Standard induced sputum collection |
| Standard First, Then Vibroacoustic Device | Experimental | 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). Receives: Device: Vibroacoustic device; Procedure: Standard induced sputum collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At each of the two sputum induction visits (Visit 1 and Visit 2, approximately 14 to 21 days apart)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Visit 1 through end of study (up to approximately 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start18 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751705
- Sponsor's protocol ID
- 26-06 BICOS
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Study of Induced Sputum Collection in COPD Patients for Assay Development With and Without a Vibroacoustic Device
- ClinicalTrials.gov ID
- NCT07751705
- Acronym / sponsor ID
- 26-06 BICOS
- Keywords
- Chronic Obstructive Pulmonary Disease, Induced Sputum, Sputum Induction, Airway Sampling, COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Aug 2026 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibroacoustic Device First, Then Standard | Experimental | Device: Vibroacoustic device, Procedure: Standard induced sputum collectionSputum 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). |
| Standard First, Then Vibroacoustic Device | Experimental | Device: Vibroacoustic device, Procedure: Standard induced sputum collectionStandard 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to give written informed consent.
- Male and female participants, aged ≥40-70 years. Women of childbearing potential (i.e. not post-menopausal, defined as amenorrhoeic for at least 12 months, and without documented surgical sterilization such as hysterectomy, bilateral oophorectomy, or tubal ligation) must not be pregnant, as confirmed by a negative urine pregnancy test prior to each sputum induction procedure, and must not be breastfeeding.
- Diagnosis of COPD based on post-bronchodilator spirometry, defined as FEV1/FVC < 0.70, consistent with GOLD criteria.
- FEV1 ≥50% of predicted (post-bronchodilator).
- Body mass index between 18 and 38 kg/m2
Key exclusion criteria (22 listed)
- Any clinically relevant disease or condition which, in the opinion of the investigator, may significantly compromise participant safety, affect study outcomes, or prevent adherence to the protocol. Explicitly excluded is cystic fibrosis or interstitial lung disease.
- Any condition that, as judged by the investigator, constitutes a contraindication or safety concern for the application of vibroacoustic chest therapy. This includes, but is not limited to:
- Initiation or discontinuation of mucolytic or expectorant agents (e.g., N-acetylcysteine, ambroxol) within 14 days prior to Visit 1 or between study visits. Participants on stable chronic mucolytic therapy (unchanged regimen for at least 4 weeks prior to Visit 1) may be enrolled provided they maintain the same regimen throughout the study.
- Treatment with systemic corticosteroids or biological therapies within 6 months prior to screening
- Treatment with antibiotics within 2 months prior to screening
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 |
|---|---|---|
| Vibroacoustic deviceA 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. | Device | Standard First, Then Vibroacoustic Device, Vibroacoustic Device First, Then Standard |
| Standard induced sputum collectionSputum 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. | Procedure or surgery | Standard First, Then Vibroacoustic Device, Vibroacoustic Device First, Then Standard |
Primary outcome
Within-subject difference in weight of selected sputum plugs (with vs. without device)
Time frame: At each of the two sputum induction visits (Visit 1 and Visit 2, approximately 14 to 21 days apart)
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.
4 secondary outcomes
Within-subject difference in procedural discomfort rating (with vs. without device)
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
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
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
Time frame: From Visit 1 through end of study (up to approximately 21 days)
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 8 Oct 2026.
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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 Vibroacoustic device and Standard induced sputum collection in people with COPD (Chronic Obstructive Pulmonary Disease), run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
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 7 inclusion and 22 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 8 Oct 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 Germany. 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 Philipp Badorrek, MD (+49 511 5350-8103, philipp.badorrek@item.fraunhofer.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-subject difference in weight of selected sputum plugs (with vs. without device) (time frame: At each of the two sputum induction visits (Visit 1 and Visit 2, approximately 14 to 21 days apart)). 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 8 Oct 2026.