Study of Long-term HFNC for COPD Patients with HOT

NCT ID: NCT03282019

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2020-10-28

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm A(myAIRVO2® + HOT)

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

Group Type: EXPERIMENTAL

High-flow nasal cannula therapy

Intervention Type: 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.

Home oxygen therapy (HOT)

Intervention Type: 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 B(HOT)

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

Group Type: ACTIVE_COMPARATOR

Home oxygen therapy (HOT)

Intervention Type: 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.

Interventions

High-flow nasal cannula therapy

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.

Intervention Type: DEVICE

Home oxygen therapy (HOT)

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.

Intervention Type: DEVICE

Other Intervention Names

myAIRVO2®

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kobe City Medical Center General Hospital

UNKNOWN

Sponsor Role: collaborator

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keisuke Tomii, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kobe City Medical Center General Hospital

Locations

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 35771533 (View on PubMed)

Other Identifiers

UMIN000028581

Identifier Type: REGISTRY

Identifier Source: secondary_id

TRIRES1668

Identifier Type: -

Identifier Source: org_study_id