Induced Sputum Collection in COPD Patients With and Without a Vibroacoustic Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorFraunhofer-Institute of Toxicology and Experimental Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 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
Trial design
Design model
Crossover
Treatments tested in this trial
Vibroacoustic device
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.
Standard induced sputum collection
Procedure/SurgerySputum 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Vibroacoustic Device First, Then StandardExperimental treatment 2 interventions
Group B: Standard First, Then Vibroacoustic DeviceExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 22
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov