Study of Long-term HFNC for COPD Patients with HOT (NCT03282019) | Clinical Trial Compass
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 range40 Years
SexALL
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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
✕. Patients with severe kidney, liver or cardiovascular disease.
✕. Patients with active malignant tumor.
✕. Patients with acute disease.
✕. Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
✕. Patients who have any history of obstructive sleep apnea syndrome (OSAS) or are highly-suspected cases in the clinical. (Excluding patients who are denied the diagnosis of OSAS by the result of overnight polysomnography.)
✕. Patients with diseases that affecting the efficacy endpoints (for example: active pulmonary infection, clinically significant pulmonary fibrosis and bronchiectasis, α-1-antitrypsin deficiency etc.,) and are regarded as inadequate for the study by the investigators.
What they're measuring
1
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
✕. Patients who have experienced a COPD exacerbation (any Severity: judged by the investigators) within the past 4 weeks prior to the informed consent.
✕. Patients who are receiving nocturnal noninvasive positive pressure ventilation (NPPV), or who had been received it within 4 weeks prior to the informed consent.