Clinical trial NCT02545855: High-flow Nasal Cannula Therapy for Stable Chronic Obstructive Pulmonary Disease (COPD)
Official title: Long-term High-flow Nasal Cannula Therapy in Patients With Stable COPD: a Prospective, Randomized Crossover 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
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Kobe City Medical Center General Hospital
First posted: 2015-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized crossover study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy with the myAIRVO2® in stable COPD patients with stage 2-4 of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and hypercapnia who require home oxygen therapy (HOT). The total duration of subject participation will be 52 weeks, consisting of 12-week treatment period and 40-week continuation period. Subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of two treatment arms, Arm A (week 1-6: the myAIRVO2® therapy plus HOT, week 7-12: HOT only) or Arm B (week 1-6: HOT only, week 7-12: the myAIRVO2® therapy plus HOT). All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. After treatment period, the willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment. The end of the study is defined as the treatment period or continuation period end date of the last participant, whichever is later. Subjects will primarily be assessed by the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at week 0, 6, 12, 24 and 52.


Eligibility criteria: Inclusion Criteria:

1. Subjects with the Global Initiative for Obstructive Lung Disease (GOLD) stage 2-4 COPD
2. Subjects who have received HOT for at least 16 hours per day for at least 1 month at the time of informed consent
3. Subjects with PaCO2 \<= 60 torr, and \>= 45 torr at the time of screening
4. Subjects who have signed written informed consent to participate in this study

Exclusion Criteria:

1. Subjects with severe kidney, liver or cardiovascular disease
2. Subjects with active malignant tumor
3. Subjects with acute disease (i.e., acute myocardial infarction)
4. Subjects with a history of obstructive sleep apnea syndrome
5. Subjects with complications affecting efficacy endpoints and who are regarded by the investigator as inadequate for this study
6. Subjects who had experienced COPD exacerbation within the past 6 weeks prior to informed consent
7. Subjects who have been receiving nocturnal noninvasive positive pressure ventilation (NPPV) or had been received within the past 6 weeks prior to informed consent
8. Subjects with a history of tracheotomy or severe pharyngeal nasal cavity surgery within the past 6 months
9. Pregnant women
10. Subjects with cognitive impairment or mental disorder and who are regarded by the investigator as inadequate to be evaluated in this study
11. Subjects who are regarded by the investigator as being unable to operate the myAIRVO2 adequately at home
12. Subjects who are participating or wil participate in the another clinical trial at the time of informed consent
13. Any other cases who are regarded by the investigator as inadequate for enrollment

Primary outcomes:
measure: Changes from baseline in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at week 6 and 12
timeFrame: Week 0, 6 and 12
Secondary outcomes:
measure: Quality-adjusted life year (QALY) by Japanese version of the EQ-5D-5L value sets
timeFrame: Week 0, 6, 12 and 52
measure: Changes from baseline in symptom, activity and impact scores of the St. George's respiratory questionnaire for COPD patients (SGRQ-C) at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: Changes from baseline in the modified medical research council (mMRC) scale at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: Changes from baseline in potential hydrogen (pH), partial pressure of oxygen (PaO2), and partial pressure of carbon dioxide (PaCO2) of the arterial blood gas analysis at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: Changes from baseline in oxygen saturation (SpO2) at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: Changes from baseline in transcutaneous carbon dioxide (PtcCO2) levels and the median - 95th percentile of nocturnal transcutaneous carbon dioxide (PtcCO2) at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: Changes from baseline in the pulmonary function tests at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: Changes from baseline in the 6-minute walk test (6MWT) scores at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: Changes from baseline in physical activity by the Lifecorder® at week 6 and 12
timeFrame: Week 0, 6 and 12
measure: COPD exacerbation in both week 1-6 and week 7-12
timeFrame: Week 1-6 and week 7-12
measure: Medication change
timeFrame: Week 1-52
measure: Oxygen flow rate at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)
timeFrame: Week 1-12
measure: Total flow rates at pre- and post-myAIRVO2® therapy in treatment period (week 1-12)
timeFrame: Week 1-12
measure: Hours of receiving the myAIRVO2® therapy in treatment period (week 1-12)
timeFrame: Week 1-12
measure: Adverse events with an undeniable causal relationship to the myAIRVO2® therapy
timeFrame: Week 1-52
Other outcomes:
measure: The ratio of subjects received the myAIRVO2® therapy plus HOT at least 1 day in continuation period (week 13-52) in subjects who completed treatment period (week 1-12)
timeFrame: Week 13-52
measure: Duration from initial date of continuation period (week 13-52) until the date of first COPD exacerbation
timeFrame: Week 13-52
measure: Chronological changes of symptom, activity and impact scores of the St. George's respiratory questionnaire for COPD patients (SGRQ-C) in subjects having a full data set at week 0, 6, 12, 24 and 52
timeFrame: Week 0, 6, 12, 24 and 52
measure: Chronological changes of the modified medical research council (mMRC) scale in subjects having a full data set at week 0, 6, 12, 24 and 52
timeFrame: Week 0, 6, 12, 24 and 52
measure: Chronological changes of potential hydrogen (pH), partial pressure of oxygen (PaO2), and partial pressure of carbon dioxide (PaCO2) of the arterial blood gas analysis in subjects having a full data set at week 0, 6, 12, 24 and 52
timeFrame: Week 0, 6, 12, 24 and 52
measure: Chronological changes of oxygen saturation (SpO2) in subjects having a full data set at week 0, 6, 12, 24 and 52
timeFrame: Week 0, 6, 12, 24 and 52
measure: Chronological changes of transcutaneous carbon dioxide (PtcCO2) levels and the median - 95th percentile of nocturnal transcutaneous carbon dioxide (PtcCO2) in subjects having a full data set at week 0, 6, 12, 24 and 52
timeFrame: Week 0, 6, 12, 24 and 52
measure: Chronological changes of the pulmonary function tests in subjects having a full data set at week 0, 6, 12, 24 and 52
timeFrame: Week 0, 6, 12, 24 and 52
Locations:
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo-prefecture
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Keisuke Tomii, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagata K, Kikuchi T, Horie T, Shiraki A, Kitajima T, Kadowaki T, Tokioka F, Chohnabayashi N, Watanabe A, Sato S, Tomii K. Domiciliary High-Flow Nasal Cannula Oxygen Therapy for Patients with Stable Hypercapnic Chronic Obstructive Pulmonary Disease. A Multicenter Randomized Crossover Trial. Ann Am Thorac Soc. 2018 Apr;15(4):432-439. doi: 10.1513/AnnalsATS.201706-425OC.