UMIN-CTR Clinical Trial

Public 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

Acronym

Study of long-term HFNC for COPD patients with HOT (FLOCOP study)

Scientific 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

Scientific Title:Acronym

Study of long-term HFNC for COPD patients with HOT (FLOCOP study)

Region

Japan

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

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

Key secondary outcomes

1. Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)
2. Term from enrollment to death from any cause
3. Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)
4. Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)
5. Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores
6. Total SRI (Severe Respiratory Insufficiency Questionnaire) score
7. Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score
8. Dyspnea intensity: the modified medical research council (mMRC) score
9. Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE
10. Oxygen Saturation (SpO2)
11. Pulmonary functions: FVC, FEV1, FEV1%
12. 6-minute walk test (6MWT): 6-minute walk test distance, SpO2, modified borg scale (mBS)
13. Term from enrollment to the date of long-term (more than 1month) NPPV(Noninvasive Positive Pressure Ventilation) usage
14. Oxygen flow rate, and Total flow rate (Arm A only)
15. Total hours of myAIRVO2-use (Arm A only)
16. Adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

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

Interventions/Control_2

Arm B (HOT):
Subjects receive following protocol treatment; HOT only within 52weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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 the diagnosis with 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, a1-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.

Target sample size

120

Name of lead principal investigator

1st name	Keisuke
Middle name
Last name	Tomii

Organization

Kobe City Medical Center General Hospital

Division name

Department of Respiratory Medicine

Zip code

650-0047

Address

2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-302-4321

Email

ktomii@kcho.jp

Name of contact person

1st name	Kazuma
Middle name
Last name	Nagata

Organization

Kobe City Medical Center General Hospital

Division name

Department of Respiratory Medicine

Zip code

650-0047

Address

2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-302-4321

Homepage URL

Email

kazuma_n1101@yahoo.co.jp

Institute

Kobe City Medical Center General Hospital
Department of Respiratory Medicine

Institute

Department

Personal name

Organization

Teijin Pharma Limited (Tokyo, Japan)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kobe University Clinical Research Ethical Committee

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe

Tel

078-382-6669

Email

cerb@med.kobe-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

06

Month

13

Day

Date of IRB

2019

Year

02

Month

14

Day

Anticipated trial start date

2017

Year

08

Month

15

Day

Last follow-up date

2020

Year

10

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

08

Day

Last modified on

2022

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032707