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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036870
Receipt No. R000042011
Scientific Title A prospective study of Chronic Obstructive Pulmonary Disease (COPD) with eosinophilia, increased FeNO or high level of serum IgE.
Date of disclosure of the study information 2019/05/28
Last modified on 2019/05/28

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Basic information
Public title A prospective study of Chronic Obstructive Pulmonary Disease (COPD) with eosinophilia, increased FeNO or high level of serum IgE.
Acronym COPD Registry
Scientific Title A prospective study of Chronic Obstructive Pulmonary Disease (COPD) with eosinophilia, increased FeNO or high level of serum IgE.
Scientific Title:Acronym COPD Registry
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this prospective study is compare eosinophil, FeNO and serum IgE levels between ACO and Non-ACO to determine clinical features from patients diagnosed with COPD for at least 2 years.
Basic objectives2 Others
Basic objectives -Others Epideminology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Exacerbation counts
2) Number of hospitalizations
3) Eosinophil
4) FeNO
5) Serum IgE
6) Spirometry
7) MMRC
8) CAT score
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Written informed consent was obtained by all patients in this study.
2) > 40 years old
3) Patients with a forced expiratory volume in one second (FEV1/FVC) less than 70 % after inhalation of a bronchodilator, and who fulfilled one of the following criteria
1 Smoking history: > 10 pack-years
2 Chest CT:emphysematous change
3 Spirometry: %DLco < 80%, or %DLco/VA < 80 %
4) Medical history of COPD > 2 Years
5) predicted postoperative(ppo)forced expiratory volume in 1 second after inhalation of a bronchodilator < 65%
6) Eosinophil > 5% or >300, FeNO > 35ppb, increased IgE level
7) CAT score > 10
Key exclusion criteria 1) oral corticosteroids administrated for at least 1 year
2) complication of malignancy disease
3) Diffuse panoramic bronchitis,congenital sinus bronchial syndrome, obstructive panbronchitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, lymphangiomyomatosis, congestive heart failure, interstitial lung disease
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takeo
Middle name
Last name Inoue
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Medicine
Zip code 2168511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL 044-977-8111
Email t2inoue@marianna-u.ac.jp

Public contact
Name of contact person
1st name Takeo
Middle name
Last name Inoue
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Medicine
Zip code 2168511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL 044-977-8111
Homepage URL
Email t2inoue@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization St. Marianna 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 St. Marianna University School of Medicine
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel 044-977-8111
Email t2inoue@marianna-u.ac.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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 28 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
2019 Year 04 Month 05 Day
Date of IRB
2019 Year 04 Month 26 Day
Anticipated trial start date
2019 Year 05 Month 28 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter, Prospective, Registry

Management information
Registered date
2019 Year 05 Month 28 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042011

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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