UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036870 |
|---|---|
| Receipt number | 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 | 2021/11/29 07:14:31 |
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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
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
t2inoue@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042011
