Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis

Launched by PHYSIO-ASSIST · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the SIMEOX device, which is designed to help patients with non-cystic fibrosis bronchiectasis—a chronic lung condition that causes mucus buildup in the airways, leading to infections and breathing problems. The trial aims to find out if using the SIMEOX device at home, along with occasional remote physiotherapy sessions, can improve patients' quality of life and decrease the frequency of lung infections over the long term compared to standard care.

To be eligible for the trial, participants must be over 18 years old and diagnosed with non-cystic fibrosis bronchiectasis, producing mucus regularly, and have had at least one serious lung infection in the past year. Patients should be stable in their condition for at least four weeks before joining. If you decide to participate, you can expect to use the SIMEOX device independently at home, which may make managing your condition easier, especially when access to physiotherapy is limited. Additionally, the trial is currently recruiting participants, so it's a great opportunity to contribute to important research that could benefit others with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female aged over 18 years
• • Predominant diagnosis of Non CF bronchiectasis disease, excluding cystic fibrosis, confirmed by computed tomography (CT).
• • Regular and chronic sputum production
• • Clinically stable at inclusion
• • Defined by a delay of at least 4 weeks since the end of the last exacerbation according to the European consensus (Hill, European Respiratory Journal, 2017)
• • No change in disease-modifying treatment for 4 weeks.
• • Having had at least two pulmonary exacerbations in the 12 months prior to inclusion and having required a change in specific treatment for these exacerbations.
• • Or Having had at least one pulmonary exacerbation in the 12 months prior to inclusion requiring hospitalisation.
• • Considered by the investigator to be physically and psychologically able to use the device and carry out the procedures under study.
• • Patient covered by a social security system, when applicable in the concerned country
• Exclusion Criteria:
• * Patients using one of the following motorised mechanical bronchial drainage devices at home at the time of inclusion:
• • SIMEOX,
• • an extra-thoracic high-frequency chest wall oscillation device (HFCWO) (The Vest,...)
• • intrapulmonary percussion ventilation (IPV)
• * Patients who have been using a powered mechanical cough aid at home for less than a year at the time of inclusion:
• • a mechanical in-exsufflator (MI E) such as the Cough Assist
• • a pressure reducer such as the Alpha300
• • Cystic fibrosis
• • Predominant diagnosis of Chronic obstructive pulmonary disease (COPD) or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis.
• • Active smoking
• • Suspected (but undiagnosed) or unstabilised immune deficiency (at investigator's discretion)
• • In the case of long-term immunosuppressive treatment, risk of discontinuation of this treatment during the study.
• • Unstable cardiovascular pathologies (acute coronary syndrome, unstable angina pectoris, uncontrolled rhythm disorders, unstable heart failure)
• • Haemodynamic instability
• • Uncontrolled gastro-oesophageal reflux (persistence of symptoms despite treatment), at investigator's discretion.
• • Acute pneumothorax or increased susceptibility to pneumothorax/pneumomediastinum
• • Inability to cough vigorously and independently, at investigator's discretion
• • Had a significant episode of haemoptysis in the 6 weeks prior to inclusion, at the discretion of the investigator
• • Patient using an endotracheal tube, tracheostomy tube or daytime ventilation \>16h with a mask
• • Patients with neuromuscular disease and respiratory muscle weakness, at the discretion of the investigator
• • Recent cardiothoracic surgery, including oesophageal surgery within 3 months of inclusion
• • Severe acute lung injury or barotrauma within 3 months of inclusion
• • Difficulty in evacuating secretions from the upper airways due to weakness of the respiratory muscles, or of the oropharyngeal or buccal musculature, at the discretion of the investigator
• • Risk of airway aspiration, e.g. from tube feeding or recent meals, at investigator's discretion
• • Inspiratory muscle weakness with inability to tolerate increased work of breathing, at investigator's discretion
• • Severe restrictive disease (Forced Vital Capacity \< 60% or Total Lung Capacity \< 60% with complete plethysmography)
• • Bullous emphysema
• • Participation in other interventional clinical study in the month prior to inclusion or during the study period
• • Patient unavailable or wishing to move to a region where the protocol is not present before the end of their participation
• * Vulnerable people:
• • pregnant women (verified by a urine or blood human chorionic gonadotropin (HCG) test for all women wishing to participate in the protocol and of childbearing age, without contraception), breastfeeding mothers or women planning to become pregnant during the period of participation in the clinical investigation
• • a person deprived of liberty by judicial or administrative decision
• • a person subject to a legal protection measure