Cystic Fibrosis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older (male or female)
• People with a confirmed diagnosis of bronchiectasis (not caused by cystic fibrosis), confirmed by a CT scan
• People who regularly and consistently produce mucus/phlegm
• People whose condition is currently stable — meaning at least 4 weeks have passed since their last lung flare-up, and no changes have been made to their main treatments in the past 4 weeks
• People who have had at least two lung flare-ups in the past 12 months that required a change in treatment, OR at least one lung flare-up in the past 12 months that required a hospital stay
• People whom the trial doctor considers physically and mentally able to use the study device and follow the study procedures
• People covered by a social security or health insurance system (where this applies in the relevant country)

Who may not be able to join:

• People who are currently using certain powered airway clearance devices at home, such as SIMEOX, a high-frequency chest wall oscillation vest (e.g. The Vest), or intrapulmonary percussion ventilation (IPV)
• People who have been using a powered mechanical cough assistance device at home for less than one year (such as the Cough Assist or Alpha300)
• People who have cystic fibrosis
• People whose main lung diagnosis is COPD, asthma, or certain other specific lung conditions (including active allergic bronchopulmonary aspergillosis, sarcoidosis, or bronchiectasis caused by a blockage or scarring in the airways)
• People who currently smoke
• People with a suspected but undiagnosed immune deficiency, or an unstable immune deficiency (confirm with trial site)
• People on long-term treatments that suppress the immune system, if there is a risk those treatments may need to be stopped during the study
• People with unstable heart conditions, such as a recent heart attack, unstable chest pain, uncontrolled heart rhythm problems, or unstable heart failure
• People with unstable blood pressure or circulation problems
• People with uncontrolled acid reflux that continues despite treatment (confirm with trial site)
• People with a current collapsed lung (pneumothorax) or a high risk of developing one
• People who are unable to cough strongly on their own (confirm with trial site)
• People who had a significant episode of coughing up blood in the 6 weeks before joining the trial (confirm with trial site)
• People who use a breathing tube, tracheostomy tube, or a breathing mask for more than 16 hours a day
• People with a neuromuscular disease that affects breathing muscle strength (confirm with trial site)
• People who have had chest or throat surgery, including oesophageal surgery, within the 3 months before joining
• People who have had a severe acute lung injury or barotrauma (pressure-related lung injury) within the 3 months before joining
• People who have difficulty clearing mucus from the upper airways due to muscle weakness in the throat, mouth, or breathing muscles (confirm with trial site)
• People at risk of inhaling food or liquid into the airways, for example due to tube feeding or eating a recent meal close to device use (confirm with trial site)
• People with breathing muscle weakness that makes it hard to tolerate extra breathing effort (confirm with trial site)
• People with severely reduced lung volume (total lung capacity below 60% on full lung function testing)
• People with large air pockets in the lungs (bullous emphysema)
• People who are currently taking part in another interventional clinical trial, or who did so in the month before joining
• People who are likely to move to an area not covered by this trial before completing their participation
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study — pregnancy is checked by a urine or blood test for women of childbearing age who are not using contraception
• People who are subject to a court or administrative order restricting their freedom
• People who are under a legal protection order

Important: Always verify eligibility with the trial site directly before applying.