CompletedNot Applicable

Study of Long-term HFNC for COPD Patients with HOT

Japan120 participantsStarted 2017-09-06

Plain-language summary

This is a prospective, randomized parallel study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy (HFNC: with the myAIRVO2 as HFNC in this study) in stable COPD patients with the global initiative for chronic obstructive lung disease (GOLD) stage 2-4, PaCO2 \>= 45 Torr and hypercapnia who require home oxygen therapy (HOT) using COPD exacerbation (Moderate or Severe).

Who can participate

Age range

40 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

. Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD.
. Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent.
. Patients with PaCO2 \>= 45 Torr and pH \>= 7.35 at screening.
. Patients with COPD exacerbation (Moderate or Severe; judged by the investigators) within the past 1 year prior to the informed consent.
. Patients who are more than 40 years old at the time of the informed consent.
. Patients who agree to participate in the study with the written informed consent.

Exclusion criteria

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

Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)

Timeframe: 52weeks

Trial details

NCT IDNCT03282019

SponsorTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-28

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease (COPD) trials