UMIN-CTR Clinical Trial

Basic information
Public title	A prospective cohort study of acute respiratory failure in idiopathic interstitial pneumonias
Acronym	AREFIP study
Scientific Title	A prospective cohort study of acute respiratory failure in idiopathic interstitial pneumonias
Scientific Title:Acronym	AREFIP study
Region	Japan

Condition
Condition	Idiopathic interstitial pneumonias (IIPs)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Prospective study of patients with acute exacerbation or acute respiratory failure, acute exacerbation of chronic respiratory failure during the course of idiopathic interstitial pneumonias
Basic objectives2	Others
Basic objectives -Others	Prospective analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Proportion and clinical characteristics of IIP cases with acute respiratory failure caused by a factor(s) other than acute exacerbation 2. Clinical characteristics, treatment responses, and prognosis of the patients with acute exacerbation according to a new classification of the severity 3. Clinical characteristics and prognosis of responders and non-responders to glucocorticoid treatment of acute exacerbation 4. Long-term QOL, respiratory function, prevalence of re-exacerbation, and prognosis observation of acute exacerbation survivors 5. Prevalence of acute exacerbation due to specific triggers (drug, surgery, infection, etc.) and their treatment response and prognosis 6. Factors associated with prognosis of acute exacerbation
Key secondary outcomes

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. Pre-existing idiopathic interstitial pneumonia is proved or suspected 2. Acute worsening or development of dyspnea within 1 month 3. Requirement for oxygen therapy to maintain SpO2 >90%, or increase in oxygen flow to maintain SpO2 >90% in cases under long-term oxygen therapy 4. New ground-glass opacity in the lungs on chest computed tomography 5. Written informed consent has been obtained
Key exclusion criteria	1. Connective tissue disease-related interstitial lung disease (CTD-ILD) 2. Hypersensitivity pneumonia 3. Cryptogenic organizing pneumonia 4. Radiation-induced lung injury 5. Pulmonary lymphangitic carcinomatosis 6. Patients who cannot perform the tests conducted in this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Asano
Organization	Tokai University School of Medicine
Division name	Division of Pulmonary Medicine, Department of Medicine
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa, Japan
TEL	+81463931121
Email	ko-asano@tokai-u.jp

Public contact
Name of contact person	1st name Takahisa Middle name Last name Takihara
Organization	Tokai University School of Medicine
Division name	Division of Pulmonary Medicine, Department of Medicine
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa, Japan
TEL	+81463931121
Homepage URL
Email	ttakihara@gmail.com

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Tokai University School of Medicine
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	Institutional Review Board for Clinical Research, Tokai University Hospital
Address	143 Shimokasuya, Isehara, Kanagawa, Japan
Tel	+81463931121
Email	tokai-rinsho@ml.tokai-u.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	東海大学医学部付属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 14 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	Preinitiation
Date of protocol fixation	2017 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date	2018 Year 06 Month 18 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2018 Year 06 Month 10 Day
Last modified on	2019 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037555