CompletedNot Applicable

Airway Clearance System (K031876) Phase IV Device Efficacy

United States16 participantsStarted 2018-02-28

Plain-language summary

Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of the thorax. The trial period shall be 21 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.

Who can participate

Age range

18 Years – 55 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: * Previously diagnosed with cystic fibrosis (mild, moderate or severe) * Prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance * Physically able to perform self-treatment or treatment by an at home medical provider Exclusion Criteria: * History of tobacco use * History of excessive alcohol consumption, more than 2 drinks per day, 10 per week * Any other medical condition that would preclude use of an airway clearance device * Previously diagnosed with major cardiological disease

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

Percentage change of oxygen levels in the blood (pulse oximetry).

Timeframe: Change from baseline up to 3.5 hours.

Trial details

NCT IDNCT03437811

SponsorMack Biotech, Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-11-01

View on ClinicalTrials.gov More Cystic Fibrosis, Pulmonary trials