UMIN-CTR Clinical Trial

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	2022 Year 04 Month 01 Day
Last follow-up date	2025 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	2021 Year 11 Month 29 Day

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