UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Anti-fibrotic treatment in patients with idiopathic pulmonary fibrosis:A cohort study
Title of the study (Brief title)	Anti-fibrotic treatment in patients with IPF:A cohort study
Region	Japan

Condition
Condition	idiopathic pulmonary fibrosis
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The outcomes of patients with idiopathic pulmonary fibrosis who undergo treatment with anti fibrotic agents (pirfenidone and nintedanib) have not been well characterized. We sought to analyze the mortality of all-cause efficacy of antifibrotic agents among a cohort of patients with IPF.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome was the association between anti fibrosis agents (pirfenidone and nintedanib) and survival in patients with IPF.
Key secondary outcomes	Other secondary outcomes included effect of pressure in the pulmonary circulation,response to inflammatory cytokine, miRNA, quality of life, and association between baseline patient characteristics and survival.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Satisfy the diagnostic criteria of IPF. 2) Anti fibroticc agents (pirfenidone or nintedanib) are administered. 3) Written informed consent.
Key exclusion criteria	without patients' consent
Target sample size	100

Research contact person
Name of lead principal investigator	keishi Oda
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Address	1-1 Iseigaoka, Yahatanishiku, Kitakyushu city
TEL	093-691-7453
Email	oda-keishi@med.uoeh-u.ac.jp

Public contact
Name of contact person	keishi Oda
Organization	University of Occupational and Environmental Health, Japan
Division name	Department of Respiratory Medicine
Address	1-1 Iseigaoka, Yahatanishiku, Kitakyushu city
TEL	093-691-7453
Homepage URL
Email	oda-keishi@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan
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)

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	産業医科大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 29 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Trial design: prospective cohort study Study enrollment: December 2015 through November 2018. Patients who visit our hospital meet inclusion criteria are enrolled. Observed parameters: Pulmonary function test, serum markers, 6-minute walk test, health-related quality of life, frequency of acute exacerbation, adverse events, pulmonary hypertension, inflammatory cytokine and blood gas analysis

Management information
Registered date	2015 Year 12 Month 29 Day
Last modified on	2017 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023549