Study of Long-term HFNC for COPD Patients with HOT

NCT03282019 | Completed DMC

• 2 other identifiers: TRIRES1668UMIN000028581
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.

  52weeks

Secondary Outcomes (16)

• Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)

  up to 52 weeks

• Term from enrollment to death from any cause

  up to 52 weeks

• Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)

  52weeks

• Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)

  at 0, 12, 24 and 52 weeks

• Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores

  at 0, 12, 24 and 52 weeks

Other Outcomes (2)

• Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of ABG change

  52weeks

• Correlation between frequency of COPD exacerbation (All Severity and Severe only) and amount of SpO2 change

  52weeks

Study Arms (2)

Arm A(myAIRVO2® + HOT)

EXPERIMENTAL

Subjects receive following protocol treatment; Home oxygen therapy (HOT) plus nocturnal high-flow nasal cannula therapy with the myAIRVO2 within 52weeks.

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

Arm B(HOT)

ACTIVE COMPARATOR

Subjects receive following protocol treatment; Home oxygen therapy (HOT) only within 52weeks.

Device: Home oxygen therapy (HOT)

Interventions

High-flow nasal cannula therapy DEVICE

Subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current Home oxygen therapy (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)

Home oxygen therapy (HOT) DEVICE

All subjects will continue their current Home oxygen therapy (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); Arm B(HOT)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.)
• Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the past 6 months prior to the informed consent.
• Patients who are pregnant.
• Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
• Patients who are regarded as being unable to operate the myAIRVO2 adequately at home by the investigators.
• Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
• Any other cases who are regarded as inadequate for the study enrollment by the investigators.

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, 6500047, Japan

Location

Related Publications (1)

• Nagata K, Horie T, Chohnabayashi N, Jinta T, Tsugitomi R, Shiraki A, Tokioka F, Kadowaki T, Watanabe A, Fukui M, Kitajima T, Sato S, Tsuda T, Kishimoto N, Kita H, Mori Y, Nakayama M, Takahashi K, Tsuboi T, Yoshida M, Hataji O, Fuke S, Kagajo M, Nishine H, Kobayashi H, Nakamura H, Okuda M, Tachibana S, Takata S, Osoreda H, Minami K, Nishimura T, Ishida T, Terada J, Takeuchi N, Kohashi Y, Inoue H, Nakagawa Y, Kikuchi T, Tomii K. Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1326-1335. doi: 10.1164/rccm.202201-0199OC.

  PMID: 35771533 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 13, 2017
• Study Start: September 6, 2017
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: November 20, 2024

Record last verified: 2021-01

Locations

JP (1)