UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients
Title of the study (Brief title)	Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients
Region	Japan

Condition
Condition	idiopathic pulmonary fibrosis
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to assess the effect of supplemental oxygen on exercise capacity in IPF patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	endurance time of constant work-rate test
Key secondary outcomes	dyspnea, leg fatigue (Borg scale) (before and every 1 minute and end of oxygen therapy)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	oxygen gas
Interventions/Control_2	air gas
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	Not applicable
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(i) diagnosis of IPF (ii) shortness of breath on effort (iii) stable clinical condition with no infection or exacerbation in the previous three months.
Key exclusion criteria	severe comorbid illnesses, collagen vascular diseases, and the need for long-term oxygen therapy.
Target sample size	106

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	Shinichi Arizono
Organization	Seirei Christopher University,
Division name	School of Health Sciences
Address	3453 Mikataha Kitaku, Hamamatsu, Shizuoka
TEL	053-439-1400
Homepage URL
Email	arizono-s@umin.ac.jp

Sponsor
Institute	Tosei General Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 01 Month 01 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2013 Year 03 Month 31 Day
Date of closure to data entry	2013 Year 03 Month 31 Day
Date trial data considered complete	2013 Year 03 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Supplemental oxygen increased endurance time than supplemental placebo air(oxygen: 546.5 sec vs placebo air: 427.8 sec, p<0.05). Dyspnea and leg fatigue at isotime were improved significantly by supplemental oxygen.
Other related information

Management information
Registered date	2016 Year 12 Month 13 Day
Last modified on	2016 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026916