UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of high-flow nasal cannula therapy on exercise tolerance in patients with stable interstitial lung disease
Title of the study (Brief title)	High-flow nasal cannula therapy for stable interstitial lung disease
Region	Japan

Condition
Condition	Interstitial lung disease
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is a prospective, randomized crossover study for evaluation the efficacy and safety of high-flow nasal cannula therapy in patients with interstitial lung disease who have oxygen desaturation during exertion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Endurance exercise time
Key secondary outcomes	1. Dyspnea intensity on exertion (modified Borg scale) 2. Desaturation during exertion(SpO2) 3. Maximum heart rate during exertion 4. Patient comfort during exertion (NRS scale) 5. Adverse events

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 Symptom limited incremental exercise tests were performed on electrically braked cycloergometer with room air or each oxygen flow at rest. On the following day, using a randomized, crossover protocol, two endurance studies were performed. The endurance study work-load was set at 80 % of the maximum work-load achieved during the prior incremental study. First day: Endurance exercise test with Venturi mask (FiO2 0.5). Second day: Endurance exercise test with high-flow nasal cannula therapy (50L/min, FiO2 0.5).
Interventions/Control_2	Arm B Symptom limited incremental exercise tests were performed on electrically braked cycloergometer with room air or each oxygen flow at rest. On the following day, using a randomized, crossover protocol, two endurance studies were performed. The endurance study work-load was set at 80 % of the maximum work-load achieved during the prior incremental study. First day: Endurance exercise test with high-flow nasal cannula therapy (50L/min, FiO2 0.5). Second day: Endurance exercise test with Venturi mask (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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with stable interstitial lung disease who have oxygen desaturation (SpO2 lower than 88%) during treadmill exercise tolerance test on room air or each oxygen flow at rest. 2. Patients who agree to participate in the study with the written informed consent.
Key exclusion criteria	1.Patients with obstructive pulmonary disease (FEV1/FVC lower than 0.7) 2.Patients with pneumothorax and/or pneumomediastinum 3.Patients with unstable diseases or the history of acute exacerbation within the last 1 month. 4.Patients with diseases affecting the outcome who regarded as inadequate for the study by the investigators. 5.Patients who have participated in the other study at the time of the informed consent, or will participate in the other study. 6.Any other patients who are regarded as inadequate for the study enrollment by the investigators.
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroyuki Taniguchi
Organization	Tosei General Hospital
Division name	Department of Respiratory Medicine and Allergy
Address	160 Nishioiwake-cho, Seto, Aichi, 489-8642 Japan
TEL	0561-82-5101
Email	taniguchi@tosei.or.jp

Public contact
Name of contact person	Atsushi Suzuki
Organization	Tosei General Hospital
Division name	Department of Respiratory Medicine and Allergy
Address	160 Nishioiwake-cho, Seto, Aichi, 489-8642 Japan
TEL	0561-82-5101
Homepage URL
Email	atsushi-salyu@hotmail.co.jp

Sponsor
Institute	Department of Respiratory Medicine and Allergy, Tosei General Hospital
Institute
Department

Funding Source
Organization	Pacific Medico Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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	公立陶生病院/Tosei General Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 04 Month 14 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 10 Month 31 Day
Date analysis concluded	2017 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 13 Day
Last modified on	2017 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025256