Induced Sputum Collection in COPD Patients With and Without a Vibroacoustic Device

Official title

Randomized Crossover Study of Induced Sputum Collection in COPD Patients for Assay Development With and Without a Vibroacoustic Device

Overview

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.

Interventions

• Device Vibroacoustic device
  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.
• Procedure Standard induced sputum collection
  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.

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• 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)]

Eligibility criteria

Inclusion criteria

• 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).
• 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

Exclusion criteria

• 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
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Basic science

Study locations

Germany · 1 center

• Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Department of Clinic — Hanover

Identifiers

NCT: NCT07751705 · 26-06 BICOS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗