Can a vibroacoustic device help COPD patients get more sputum when they inhale saline mist
Official title: Randomized Crossover Study of Induced Sputum Collection in COPD Patients for Assay Development With and Without a Vibroacoustic Device
Run by Fraunhofer-Institute of Toxicology and Experimental Medicine · NCT07751705 · Data updated 2026-11-12
This study tests whether adding a vibroacoustic device during induced sputum collection helps COPD patients produce more sputum.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fraunhofer-Institute of Toxicology and Experimental Medicine Academic / other |
| Locations | 1 site (Hanover, Lower Saxony) |
| Status | Recruiting |
| Started | August 18, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07751705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40-70 with COPD confirmed by post-bronchodilator spirometry (FEV1/FVC < 0.70 and FEV1 ≥ 50% predicted).
✕Probably not a fit
Patients for whom sputum yield does not increase with the device or who poorly tolerate the procedure may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this study, COPD patients undergo two sputum inductions on separate days, one with the vibroacoustic device and one without, in random order. The goal is to compare the amount of sputum collected in the same person under both conditions. Researchers also track how well participants tolerate the procedure. The design is a within-subject comparison to isolate the device’s effect on sputum yield and tolerability.
Why it matters
Potential benefit: If successful, the device could improve sputum collection efficiency for research and clinical assessment in COPD.
How similar studies have gone: Previous research has explored device-assisted airway sampling; this study adds a randomized within-subject comparison in COPD.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able and willing to give written informed consent. 2. 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. 3. Diagnosis of COPD based on post-bronchodilator spirometry, defined as FEV1/FVC \< 0.70, consistent with GOLD criteria. 4. FEV1 ≥50% of predicted (post-bronchodilator). 5. Body mass index between 18 and 38 kg/m2 6. 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. 7. 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 Exclusion Criteria: 1. 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. 2. 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 * 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 3. 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. 4. Treatment with systemic corticosteroids or biological therapies within 6 months prior to screening 5. Treatment with antibiotics within 2 months prior to screening 6. Lower respiratory tract infection within 4 weeks prior to screening 7. Upper respiratory tract infection within 2 weeks prior to screening 8. History of drug or alcohol abuse within 12 months prior to screening 9. Participation in a clinical trial involving an investigational medicinal product within 6 months prior to screening 10. 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).
Where it's running
-
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Department of Clinical Airway Research
Hanover, Lower Saxony, Germany Recruiting
Study contacts
- Study coordinator: Philipp Badorrek, MD
- Email: philipp.badorrek@item.fraunhofer.de
- Phone: +49 511 5350-8103
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.