High-flow Nasal Cannula Therapy for Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT02545855 | Completed

• 2 other identifiers: TRIRES1507UMIN000017639
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

myAIRVO2; high-flow nasal cannula therapy; home oxygen therapy; HOT

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) total score at week 6 and 12

  Week 0, 6 and 12

Secondary Outcomes (15)

• Quality-adjusted life year (QALY) by Japanese version of the EQ-5D-5L value sets

  Week 0, 6, 12 and 52

• 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

  Week 0, 6 and 12

• Changes from baseline in the modified medical research council (mMRC) scale at week 6 and 12

  Week 0, 6 and 12

• 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

  Week 0, 6 and 12

• Changes from baseline in oxygen saturation (SpO2) at week 6 and 12

  Week 0, 6 and 12

Other Outcomes (8)

• 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)

  Week 13-52

• Duration from initial date of continuation period (week 13-52) until the date of first COPD exacerbation

  Week 13-52

• 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

  Week 0, 6, 12, 24 and 52

Study Arms (2)

Arm A (myAIRVO2® + HOT, HOT)

EXPERIMENTAL

Subjects will receive the myAIRVO2® therapy plus HOT for week 1-6 and HOT only for week 7-12. After treatment period (week 1-12), willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment.

Device: High-flow nasal cannula therapy; Device: Home oxygen therapy (HOT)

Arm B (HOT, myAIRVO2® + HOT)

EXPERIMENTAL

Subjects will receive HOT only for week 1-6 and the myAIRVO2® therapy plus HOT for week 7-12. After treatment period (week 1-12), willing subjects can continue the myAIRVO2® therapy plus HOT for week 13-52 regardless of treatment arm assignment.

Device: High-flow nasal cannula therapy; Device: Home oxygen therapy (HOT)

Interventions

High-flow nasal cannula therapy DEVICE

All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. The myAIRVO2® is used for at least 4 hours per day with flow rates in the range 30-40 L/min. The investigator can adjust the nocturnal oxygen flow rates to keep SpO2 88-92% stably. If the subjects report discomfort, the investigator can adjust the flow rates in the range at least 20 L/min.

Also known as: myAIRVO2®

Arm A (myAIRVO2® + HOT, HOT); Arm B (HOT, myAIRVO2® + HOT)

Home oxygen therapy (HOT) DEVICE

All subjects will continue their current HOT which kept original usage conditions at the time of enrollment throughout the entire duration of the study regardless of treatment arm assignment.

Arm A (myAIRVO2® + HOT, HOT); Arm B (HOT, myAIRVO2® + HOT)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Kobe City Medical Center General Hospital: collaborator

Study Sites (1)

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Related Publications (1)

• 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.

  PMID: 29283682 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keisuke Tomii, MD, Ph.D.

  Kobe City Medical Center General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 10, 2015
• Study Start: August 17, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

JP (1)