Bronchiectasis, Mucus; Plug
Conditions
Keywords
Bronchiectasis, Mucus hypersecretion, Airway clearance technique, Bronchial drainage
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntermittent intrapulmonary deflation
Two treatment sessions daily for two weeks
Sponsors
Inogen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months 2. Persistent productive cough for which daily airway clearance therapy is prescribed. 3. Daily sputum production estimated at \> 1 tsp or 5 ml 4. Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment 5. Subject able to sign informed consent
Exclusion criteria
1. Inability to cough forcefully and independently, as determined by the clinician 2. Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP) 3. Neuromuscular disease with muscle respiratory weakness 4. Severe restrictive lung disease defined as Forced Vital Capacity (FVC) \<60% of predicted 5. Unstable cardiac disease (e.g. major cardiac arrhythmia, unstable heart failure, heart attack, unstable angina) 6. Hemodynamic instability, as determined by the clinician 7. Airway at risk for aspiration, as determined by the clinician 8. Uncontrolled gastroesophageal reflux disease (GERD) as determined by the clinician 9. Upper airway surgery in the prior 3 months 10. Cardiothoracic surgery, including esophageal surgery, in the prior 6 months 11. Anticipated hospitalization within the next 2 weeks 12. History of pneumothorax within the prior 6 months 13. History of haemoptysis treated with embolization within the prior 12 months 14. Inability to use airway clearance therapy as directed 15. Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol 16. Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wet sputum weight collected with Simeox 200 during device training visit | From the first training session to the last, and up to one hour following each treatment session the day of training device visit. | Patients will be instructed during device training visit (V1) to spill all sputum into a pre-weighed pot from at least two supervised sessions. Immediately after collection, all sputum will be weighed on weighing scales with an accuracy of 0.01 grams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Forced Expiratory Volume in One seconde (FEV1) at the final study visit (V2) after 14 days of treatment | From enrollment to the final study visit at 15 days | FEV1will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site |
| Change from baseline in Forced Vital Capacity (FVC) at the final study visit after 14 days of treatment | From enrollment to the final study visit at 15 days | FVC will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site |
| 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 | From enrollment to the final study visit at 15 days | FEF25-75% will be measured with a spirometer according to the ATS guidelines immediately before any procedures at the study site |
| Change from baseline in Peripheral blood oxygen saturation (SpO2) at final study visit after 14 days of treatment | From enrollment to the final study visit at 15 days | SpO2 will be measured transcutaneously at rest with a fingertip pulse oximeter before lung function measurements at rest and any procedures with the device at the study site |
| Change from baseline in perceived respiratory symptoms assessed with the Breathlessness, Cough and Sputum Scale (BCSS) at 7 and 14 days of treatment | From enrollment to 7 and 14 days of treatment at home | BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms breathing difficulty, cough, and sputum levels, each on a 5-point scale from 0 (no symptom) to 4 (highest severe symptom) |
| The change from device training visit in wet sputum weight at the final study visit after 14 days of treatment | From device training visit to the final study visit at 15 days | Patients will be instructed to spill all sputum into a pre-weighed pot. Immediately after collection, all sputum will be weighed on weighing scales with an accuracy of 0.01 grams. |
| 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 | From enrollment to the final study visit at 15 days | The CAAT is an 8-item questionnaire designed for assessing the impact of a chronic respiratory disease such as bronchiectasis on a person's life. The questionnaire covers symptoms (such as cough, sputum, chest tightness and breathlessness) and disease impacts (including physical activity, confidence, sleep and energy) assessed each on a 6-point scale from 0 (best outcome) to 5 (worst outcome). The QOL-B on the other hand is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients bronchiectasis. |
| The change from baseline in walking distance assessed with 6-minutes Walking Test (6MWT) at the final study visit after 14 days of treatment | From enrollment to the final study visit at 15 days | The 6MWT is a low-intensity, submaximal exercise test used to assess aerobic capacity and endurance and oxygen saturation. 6MWT will be performed after spirometry assessment and in accordance with ATS guidelines. SpO2 will be measured transcutaneously at rest for 5 min before, during and at the end of the 6MWT. A modified Borg scale will be completed beofre and at the end of 6MWT for dyspnea and fatigability scores. |
| 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. | From enrollment to the final study visit at 15 days | The 6MWT is a low-intensity, submaximal exercise test used to assess aerobic capacity and endurance and oxygen saturation. 6MWT will be performed after spirometry assessment and in accordance with ATS guidelines. SpO2 will be measured transcutaneously at rest for 5 min before, during and at the end of the 6MWT. A modified Borg scale will be completed before and at the end of 6MWT for dyspnea and fatigability scores. |
| The global patient satisfaction will be evaluated with Lickert scale at the final study visit after 14 days of treatment | At the final study visit at 15 days | Likert scale measures respondents' level of agreement/satisfaction or disagreement/dissatisfaction towards the treatment on the following attributes: overall / learning time / easy to handle / subjective effectiveness / treatment duration / use in autonomy. These rating scales offer 10 response options, ranging from 0 (worst outcome) to 10 (best outcome). |
| Adherence to the device over the entire period of home use | From the first day of device use at home to the 14 days of home treatment | The patient will record adherence to Simeox 200 on a daily diary at home, noting the number of sessions per day and the duration of each session. |
Countries
United States
Contacts
CONTACTRoxanna Edwards
CONTACTChief Medical Officer
PRINCIPAL_INVESTIGATORPatrick A Flume, MD
Medical University of South Carolina
Outcome results
None listed