Clinical trial NCT03282019: Study of Long-term HFNC for COPD Patients with HOT
Official title: Efficacy and Safety of Long-term High-flow Nasal Cannula Oxygen Therapy in Stable COPD Patients with Home Oxygen Therapy (HOT): a Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: myAIRVO2
high-flow nasal cannula therapy
home oxygen therapy
HOT
COPD
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Kobe City Medical Center General Hospital
First posted: 2017-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: An abroad study of the stable COPD patients was reported that HFNC usage decreased the frequency of COPD exacerbation.

In addition, the result of the pilot study (NCT02545855) of the stable COPD patient in Japan is indicated that HOT with HFNC improved their QOL and PaCO2 by comparing to HOT only.

Therefore, this study is planned to indicate the efficacy of HFNC which can increase the ventilation efficiency and have the function of heated humidification, by comparing HOT with HFNC to HOT only.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with severe kidney, liver or cardiovascular disease.
2. Patients with active malignant tumor.
3. Patients with acute disease.
4. Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
5. 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.)
6. 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.
7. Patients who have experienced a COPD exacerbation (any Severity: judged by the investigators) within the past 4 weeks prior to the informed consent.
8. Patients who are receiving nocturnal noninvasive positive pressure ventilation (NPPV), or who had been received it within 4 weeks prior to the informed consent.
9. Patients who have used HFNC at home within the past 1 year prior to the informed consent, or are using any HFNC. (Excluding patients who used HFNC during hospitalization due to acute respiratory failure within 1 year prior to the informed consent.)
10. Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the past 6 months prior to the informed consent.
11. Patients who are pregnant.
12. Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
13. Patients who are regarded as being unable to operate the myAIRVO2 adequately at home by the investigators.
14. Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
15. Any other cases who are regarded as inadequate for the study enrollment by the investigators.

Primary outcomes:
measure: Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
timeFrame: 52weeks
Secondary outcomes:
measure: Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)
timeFrame: up to 52 weeks
measure: Term from enrollment to death from any cause
timeFrame: up to 52 weeks
measure: Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)
timeFrame: 52weeks
measure: Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)
timeFrame: at 0, 12, 24 and 52 weeks
measure: Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores
timeFrame: at 0, 12, 24 and 52 weeks
measure: Total SRI (Severe Respiratory Insufficiency Questionnaire) score
timeFrame: at 0, 12, 24 and 52 weeks
measure: Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score
timeFrame: at 0, 12, 24 and 52 weeks
measure: Dyspnea intensity: the modified medical research council (mMRC) score
timeFrame: 52weeks
measure: Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
timeFrame: 52weeks
measure: Oxygen Saturation (SpO2)
timeFrame: 52weeks
measure: Pulmonary functions: FVC, FEV1, FEV1%
timeFrame: 52weeks
measure: 6-minute walk test (6MWT)
timeFrame: at 0, 12, 24 and 52 weeks
measure: Term from enrollment to the date of long-term (more than 1month) NPPV(Noninvasive Positive Pressure Ventilation) usage
timeFrame: 52weeks
measure: Flow rate(Oxygen / Total) (Arm A only)
timeFrame: 52weeks
measure: Total hours of myAIRVO2-use (Arm A only)
timeFrame: 52weeks
measure: Adverse events
timeFrame: 52weeks
Other outcomes:
measure: Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of ABG change
timeFrame: 52weeks
measure: Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of SpO2 change
timeFrame: 52weeks
Locations:
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Keisuke Tomii, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: