UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027844
Receipt number R000031899
Scientific Title Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Date of disclosure of the study information 2017/07/01
Last modified on 2020/06/13 16:54:36

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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 or person

Institute

National Hospital Organization Kinki-Chuo Chest Medical Center

Institute

Department

Personal name



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

Value
https://center6.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