UMIN-CTR Clinical Trial

Basic information
Public title	Effect of high-flow nasal cannula oxygen therapy on exercise capacity in patients with Idiopathic Pulmonary Fibrosis
Acronym	Effect of high-flow nasal cannula oxygen therapy in patients with Idiopathic Pulmonary Fibrosis
Scientific Title	Effect of high-flow nasal cannula oxygen therapy on exercise capacity in patients with Idiopathic Pulmonary Fibrosis
Scientific Title:Acronym	Effect of high-flow nasal cannula oxygen therapy in patients with Idiopathic Pulmonary Fibrosis
Region	Japan

Condition
Condition	Idiopathic Pulmonary Fibrosis
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of high-flow nasal cannula oxygen therapy for exercise duration in patients with idiopathic pulmonary fibrosis who have exertion induced hypoxemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Endurance time of exercise
Key secondary outcomes	1. Dyspnea (modified Borg Scale) 2. Fatigue of lower limb (modified Borg Scale) 3. Desaturation (SpO2) 4. Heart rate 5. Blood pressure 6. Patient comfort to each device (Visual Analog Scale)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Arm A A symptom-limited incremental exercise tests were carried out on cycle-ergometer with ambient air. Next time, patient performed constant-load symptom-limited exercise test in a random order arm A or arm B. A constant-load exercise test was performed at 80% of maximum workload achieved with the incremental test. First time: constant-load exercise test with high-flow nasal cannula (60L/min, FiO2:0.5) Second time: constant-load exercise test with venturi mask (FiO2:0.5).
Interventions/Control_2	Arm B A symptom-limited incremental exercise tests were carried out on cycle-ergometer with ambient air. Next time, patient performed constant-load symptom-limited exercise test in a random order arm A or arm B. A constant-load exercise test was performed at 80% of maximum workload achieved with the incremental test. First time: constant-load exercise test with venturi mask (FiO2:0.5) Second time: constant-load exercise test with high-flow nasal cannula (60L/min, FiO2:0.5).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient aged =<40 years at informed consent 2. Patient with idiopathic pulmonary fibrosis diagnosed according to the diagnostic criteria of INPULSIS trial and 2011 or 2018 ATS/ERS/JRS/ALAT guideline 3. Patients who have exercise induced oxygen desaturation (SpO2 <90%) during 6 minute walking test on ambient air 4. Patient with dyspnea on exercise (1 =< mMRC =< 3) 5. Stable patients without any infection nor acute exacerbation within 3 months 6. Patients who can see a doctor's visit to take outpatient rehabilitation program 7. Patients who can adequately answer the questionnaire about subjective symptom 8. Written informed consent is obtained
Key exclusion criteria	1. Patients with connective tissue disease, neuromuscular disease or orthopedic problem and other disease which may affect to exercise assessment and requires exercise limitation 2. Patients who have pulmonary hypertension, according to WHO guideline [I-II => NYHA and 25mmHg => mean pulmonary arterial pressure (40mmHg => TRPG)] and use a pulmonary vasodilator 3. Using an anti-arrhythmic drug 4. Using long-term oxygen therapy 5. Patients who cannot be evaluated by 6 minute walk test for any reason 6. Patients who are judged by the investigator as not adequate to participate in this study 7. History of malignant disease within 3 years
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Iwata
Organization	Kobe City Medical Center General Hospital
Division name	Kobe City Medical Center General Hospital
Zip code	6500047
Address	2-1-1 Minatojima-minamimachi, Chuo-ward, Kobe-city, Hyogo
TEL	078-302-4321
Email	iwaken@kcho.jp

Public contact
Name of contact person	1st name Jumpei Middle name Last name Harada
Organization	Kobe City Medical Center General Hospital
Division name	Department of Rehabilitation
Zip code	6500047
Address	2-1-1 Minatojima-minamimachi, Chuo-ward, Kobe-city, Hyogo
TEL	078-302-4321
Homepage URL
Email	jumpei_harada@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital Department of Rehabilitation
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe City Medical Center General Hospital IRB
Address	2-1-1 Minatojima-minamimachi, Chuo-ward, Kobe-city, Hyogo
Tel	078-302-4321
Email	rinken@kcho.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	26
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

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 10 Month 28 Day
Date of IRB	2019 Year 10 Month 29 Day
Anticipated trial start date	2019 Year 12 Month 23 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 20 Day
Last modified on	2020 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044403