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New treatment option for Non-cystic Fibrosis Bronchiectasis
Official title Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
ClinicalTrials.gov ID: NCT06487273
What this study is testing
- What it's testing
- Bronchiectasis is a chronic lung disease of multiple aetiologies characterised by permanent dilatation of the calibre of a territory of the bronchial tree with impaired mucociliary clearance. This alteration causes mucus retention, leading to infections and chronic bronchial inflammation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- 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...
- 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 (Total Lung Capacity \< 60% with complete plethysmography)
- Bullous emphysema
- Participation in other treatment 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...
- a person deprived of liberty by judicial or administrative decision
- a person subject to a legal protection measure
The study team makes the final eligibility decision.
Where it's taking place
- Abbeville, France
- Aix-en-Provence, France
- Albi, France
- Amiens, France
- Angers, France
- Annecy, France
- Aressy, France
- Brest, France
- Cherbourg, France
- Compiègne, France
- Contamine-sur-Arve, France
- Créteil, France
- Dieulefit, France
- Grenoble, France
- Hyères, France
- La Rochelle, France
- Le Kremlin-Bicêtre, France
- Le Puy-en-Velay, France
- Libourne, France
- Limoges, France
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abbeville, France; Aix-en-Provence, France; Albi, France; Amiens, France; Angers, France; Annecy, France and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.