UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Acronym	Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study)
Scientific Title	Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Scientific Title:Acronym	Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study)
Region	Japan

Condition
Condition	acute deterioration of interstitial lung diseases
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between prognosis and clinical factors in interstitial lung diseases after the deterioration of dyspnea with new pulmonary shadows
Basic objectives2	Others
Basic objectives -Others	To make new diagnostic criteria of acute exacerbation of interstitial lung diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical factors to determine 3-month survival of acute deterioration in interstitial lung diseases
Key secondary outcomes	1)Clinical factors to determine 1-year survival of acute deterioration in interstitial lung diseases 2)Change of clinical parameters after acute deterioration of ILDs 3)Therapy 4)Cause of death 5)Adverse events 6)Efficacy of present diagnostic criteria of acute exacerbation 7)Comparison of present diagnostic criterion of acute exacerbation 8)To make a new diagnostic criteria of acute exacerbation of ILDs

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) idiopathic interstitial pneumonias (IIPs) and interstitial lung diseases (ILDs) other than IIPs including chronic hypersensitivity pneumonia, collagen vascular diseases-ILDs and asbestosis 2) Cases that deteriorated with deterioration of dyspnea and newly developed pulmonary shadows.
Key exclusion criteria	1) Survival is supposed to be less than 3 months due to complications of ILDs 2) Cases that researchers have determined to be improper for inclusion
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Arai
Organization	NHO Kinki-Chuo Chest Medical Center
Division name	Clinical Research Center
Zip code	591-8555
Address	1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL	072-252-3021
Email	arai.toru.cp@mail.hosp.go.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Matsui
Organization	NHO Kinki-Chuo Chest Medical Center
Division name	Clinical Research Center
Zip code	591-8555
Address	1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL	072-252-3021
Homepage URL
Email	matsui.yuki.yx@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Kinki-Chuo Chest Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization
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	Review board of NHO Kinki-Chuo Chest Medical Center
Address	1180 Nagasone-Cho, Kita-Ku, Sakai Osaka, Japan
Tel	072-252-3021
Email	agata.yuka.zd@mail.hosp.go.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	H28-NHO(Kokyu)-02
Org. issuing International ID_1	National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 01 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	416
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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 02 Day
Date of IRB	2017 Year 04 Month 13 Day
Anticipated trial start date	2017 Year 06 Month 09 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Birth month, gender, past history, complications, smoking status, height, weight, physical examination, radiological findings, laboratory findings, therapy, clinical course, outcome, last follow-up date

Management information
Registered date	2017 Year 06 Month 20 Day
Last modified on	2020 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031899

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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