UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of a portable oxygen concentrator for patients with chronic lung disease
Acronym	Efficacy of a portable oxygen concentrator
Scientific Title	Efficacy of a portable oxygen concentrator for patients with chronic lung disease
Scientific Title:Acronym	Efficacy of a portable oxygen concentrator
Region	Japan

Condition
Condition	chronic lung disease (COPD and chronic interstitial pneumonia)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the efficacy of a portable oxygen concentrator for patients with chronic lung disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Required oxygen flow rate on pure oxygen, stationary oxygen concentrator, and portable oxygen concentrator
Key secondary outcomes	Required oxygen flow rate on pure oxygen, stationary oxygen concentrator, and portable oxygen concentrator on exertion and during sleep

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Oxygen therapy with pure oxygen, stationary oxygen concentrator, and portable oxygen concentrator
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who were diagnosed with COPD or chronic interstitial pneumonia. 2. Patients who will newly start domiciliary oxygen therapy or who are already undergoing the therapy but need to adjust the flow rate. 3. Patients who can operate the portable oxygen concentrator. 4. Patients who can deal with the trouble of the portable oxygen concentrator. 5. Patients who can provide written informed consents.
Key exclusion criteria	1. Patients who cannot undergo walk tests. 2. Patients whose oxygen saturation cannot be measured. 3. Patients who need nocturnal noninvasive ventilation.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Osamu Nishiyama
Organization	Kinki University, Faculty of Medicine
Division name	Department of Respiratory Medicine and Allergology
Zip code
Address	377-2 Onohigashi, Osaka-sayama, Osaka 589-8511, Japan
TEL	072-366-0221
Email	nishi-o@med.kindai.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Osamu Nishiyama
Organization	Kinki University, Faculty of Medicine
Division name	Department of Respiratory Medicine and Allergology
Zip code
Address	377-2 Onohigashi, Osaka-sayama, Osaka 589-8511, Japan
TEL	072-366-0221
Homepage URL
Email	nishi-o@med.kindai.ac.jp

Sponsor
Institute	Department of Respiratory Medicine and Allergology, Kinki University, Faculty of Medicine
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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	近畿大学病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 12 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
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	2014 Year 03 Month 01 Day
Date of IRB	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 05 Month 12 Day
Last follow-up date	2019 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	2014 Year 05 Month 01 Day
Last modified on	2019 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016170