Randomized Crossover Study of Induced Sputum Collection in COPD Patients for Assay Development With and Without a Vibroacoustic Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Within-subject difference in weight of selected sputum plugs (with vs. without device)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Vibroacoustic Device First, Then Standard
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).
干预措施: Standard induced sputum collection (Procedure)
Vibroacoustic Device First, Then Standard
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).
干预措施: Vibroacoustic device (Device)
Standard First, Then Vibroacoustic Device
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).
干预措施: Vibroacoustic device (Device)
Standard First, Then Vibroacoustic Device
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).
干预措施: Standard induced sputum collection (Procedure)
结局指标
主要结局
Within-subject difference in weight of selected sputum plugs (with vs. without device)
时间窗: 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.
次要结局
- Within-subject difference in procedural discomfort rating (with vs. without device)(Immediately after each sputum induction procedure at Visit 1 and Visit 2)
- Proportion of participants willing to undergo the device-assisted procedure again(At the device-assisted procedure (Day 1 or Day 14, up to Day 21))
- Proportion of participants completing all device-assisted inhalation periods(At the device-assisted procedure (Day 1 or Day 14, up to Day 21))
- Incidence, nature, and severity of procedure-related adverse events(From Visit 1 through end of study (up to approximately 21 days))