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.
Able and willing to give written informed consent.
Male and female participants, aged 40-70 years, inclusive. 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 between 50% and 80% of predicted (post-bronchodilator).
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