Simeox 200 US Study

Официальное название

A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients With Chronic Mucus Hypersecretion

Обзор

The purpose of this single arm post-market observational study is to evaluate the short-term effectiveness of the Simeox 200 airway clearance device in improving airway clearance in adult patients aged 18 to 85 with bronchiectasis and chronic mucus hypersecretion. The study aims to establish a baseline for wet sputum weight production using the Simeox 200 device. Additionally, the study aims to assess the short-term effects of Simeox 200 on various outcomes, including lung function, respiratory symptoms, and health-related quality of life. The study participants will undergo the following steps: 1. Baseline Visit (V0): Participants will attend a baseline visit for eligibility screening, consent, a physical exam, and baseline assessments of various relevant parameters such as lung function, SpO2, and Patient-Reported-Outcomes. 2. Treatment Sessions (V1): Participants will perform two supervised treatment sessions with the Simeox 200 device at the clinic, during which sputum will be collected and weighed. 3. Home Use : Participants will use the device at home twice daily for 2 weeks, recording their usage and symptoms in a daily electronic diary. 4. Final Clinic Visit (V2): Participants will return for a final clinic visit for repeat assessments. 5. Follow-up Phone Call (14 days after V2): Participants will receive a follow-up phone call to assess ongoing symptoms and health status.

Подробное описание

Airway clearance techniques (ACTs) are essential for removing excess bronchial secretions and preventing airway complications. However, their effectiveness relies on patient adherence and satisfaction. Simoex 200 is a novel airway clearance device that uses intermittent negative oscillating pressure to mobilize airway secretions from different parts of the lungs to central airways, facilitating expectoration. Preliminary studies in Europe on patients with chronic muco-obstructive lung diseases have demonstrated the effectiveness and good tolerance of previous generations of the device. This pilot study will evaluate the Simeox 200 device in a home care setting for patients with bronchiectasis and excessive mucus production. The results of this study will inform a future larger-scale clinical trial.

Вмешательства

• Устройство Intermittent intrapulmonary deflation
  Two treatment sessions daily for two weeks

Первичные конечные точки

• Wet sputum weight collected with Simeox 200 during device training visit [Срок оценки: From the first training session to the last, and up to one hour following each treatment session the day of training device visit.]

Вторичные конечные точки (11)

• Change from baseline in Forced Expiratory Volume in One seconde (FEV1) at the final study visit (V2) after 14 days of treatment [Срок оценки: From enrollment to the final study visit at 15 days]
• Change from baseline in Forced Vital Capacity (FVC) at the final study visit after 14 days of treatment [Срок оценки: From enrollment to the final study visit at 15 days]
• Change from baseline in Forced Expiratory Flow between 25% and 75% of vital capacity (FEF25-75%) at the final study visit after 14 days of treatment [Срок оценки: From enrollment to the final study visit at 15 days]
• Change from baseline in Peripheral blood oxygen saturation (SpO2) at final study visit after 14 days of treatment [Срок оценки: From enrollment to the final study visit at 15 days]
• Change from baseline in perceived respiratory symptoms assessed with the Breathlessness, Cough and Sputum Scale (BCSS) at 7 and 14 days of treatment [Срок оценки: From enrollment to 7 and 14 days of treatment at home]
• The change from device training visit in wet sputum weight at the final study visit after 14 days of treatment [Срок оценки: From device training visit to the final study visit at 15 days]
• The change from baseline in airway-disease health status assessed by the Chronic Airway Assessement Test (CAAT) and QOL - B questionnaire at the final study visit after 14 days of treatment [Срок оценки: From enrollment to the final study visit at 15 days]
• The change from baseline in walking distance assessed with 6-minutes Walking Test (6MWT) at the final study visit after 14 days of treatment [Срок оценки: From enrollment to the final study visit at 15 days]
• The change from baseline in borg dyspnea and fatigue score after 6MWT compared to borg dyspnea and fatigue score after 6MWT at the final study visit after 14 days of treatment respectively. [Срок оценки: From enrollment to the final study visit at 15 days]
• The global patient satisfaction will be evaluated with Lickert scale at the final study visit after 14 days of treatment [Срок оценки: At the final study visit at 15 days]
• Adherence to the device over the entire period of home use [Срок оценки: From the first day of device use at home to the 14 days of home treatment]

Критерии участия

Критерии включения

• Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months
• Persistent productive cough for which daily airway clearance therapy is prescribed.
• Daily sputum production estimated at > 1 tsp or 5 ml
• Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment
• Subject able to sign informed consent

Критерии исключения

• Inability to cough forcefully and independently, as determined by the clinician
• Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP)
• Neuromuscular disease with muscle respiratory weakness
• Severe restrictive lung disease defined as Forced Vital Capacity (FVC) <60% of predicted
• Unstable cardiac disease (e.g. major cardiac arrhythmia, unstable heart failure, heart attack, unstable angina)
• Hemodynamic instability, as determined by the clinician
• Airway at risk for aspiration, as determined by the clinician
• Uncontrolled gastroesophageal reflux disease (GERD) as determined by the clinician
• Upper airway surgery in the prior 3 months
• Cardiothoracic surgery, including esophageal surgery, in the prior 6 months
• Anticipated hospitalization within the next 2 weeks
• History of pneumothorax within the prior 6 months
• History of haemoptysis treated with embolization within the prior 12 months
• Inability to use airway clearance therapy as directed
• Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
• Pregnant or lactating female

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07443124 · SIM200-NCFB-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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