CompletedNot Applicable

Evaluation of an Airway Clearance System

Belgium9 participantsStarted 2017-03-30

Plain-language summary

The aim of this study is to assess the effectiveness of an Airway Clearance System.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented diagnosis of Cystic Fibrosis (CF) (by sweat test and/or genetics) * Age ≥ 15 years * Ability to expectorate sputum daily - determined by treating physician * Patient must be on a stable regimen of CF medication for 4 weeks prior to Visit 1 * Patient who requires regular home airway clearance therapy Exclusion Criteria: * Forced Expiratory Volume in 1 Second (FEV1) \< 30 % predicted or \> 90 % predicted * Anticipated requirement for hospitalization within the next three weeks * History of pneumothorax within the past 6 months prior Visit 1 * History of haemoptysis requiring embolization within the past 12 months prior to Visit 1 * Inability to perform Monarch™ and/or Vest® System therapy as directed * Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol * Has taken Intravenous (IV) antibiotics within the past 4 weeks prior to Visit 1 * Has ongoing exacerbation or Allergic bronchopulmonary aspergillosis (ABPA) * Pregnant or lactating female * Has a pacemaker or implantable cardioverter defribillator (ICD)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wet Weight of Sputum Produced

Timeframe: Through study completion, an average of 2 months

Trial details

NCT IDNCT03091062

SponsorHill-Rom

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-02

View on ClinicalTrials.gov More Cystic Fibrosis trials

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.