UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055706 |
|---|---|
| Receipt number | R000063399 |
| Scientific Title | Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD) |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/11/13 12:23:36 |
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Basic information
Public title
Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD)
Acronym
Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD)
Scientific Title
Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD)
Scientific Title:Acronym
Prospective study for the association between productive cough and mucus plugs in the pathogenesis of chronic obstructive pulmonary disease (COPD)
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on the cough/sputum symptoms of COPD patients and mucus plugs on images, COPD patients will be divided into a group with wet cough, a group with dry cough, and a group with no cough, and the occurrence of exacerbations or deaths will be prospectively observed.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between cough/sputum symptoms and mucus plugs on imaging in COPD patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the frequency of COPD exacerbations and deaths among patients with wet cough, those with dry cough, and those without cough.
Key secondary outcomes
We will compare chest CT mucus plug scores, emphysema scores, degree of airway wall thickness, frequency of sinusitis, frequency of heart disease, BNP values, peripheral blood eosinophil/neutrophil counts, non-specific IgE, presence or absence of allergen sensitization, serum biomarkers (IL-8, IL-33, etc.), exhaled NO value, and pulmonary function in patients with wet cough, dry cough, and no cough. We will also analyze changes in these clinical indicators and the incidence of COPD exacerbations, hospitalization rates, and mortality rates during the observation period.
In cases who were able to expectorate sputum (mainly the group with wet cough), we will analyze the types of bacterial flora in sputum cultures and the incidence of COPD exacerbations, hospitalization rates, and mortality rates.
In addition, only in cases where testing was possible, we will analyze the relationship between capsaicin cough sensitivity, cell fractions in induced sputum, biomarkers in sputum supernatant (IL-8, IL-33, etc.) and the incidence of COPD exacerbations during the observation period, hospitalization rate, mortality rate, mucus plug score on chest CT, emphysema score, airway wall thickness, presence or absence of allergen sensitization, serum biomarkers (IL-8, IL-33, etc.), exhaled NO value, lung function, etc.
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. Patients who are visiting the research institution
2. Patients who have been definitively diagnosed with COPD and are currently undergoing treatment
3. Patients who are 20 years of age or older on the day of enrollment
4. Patients who have given written consent to participate in this study
Key exclusion criteria
1. Patients with other obvious respiratory diseases such as lung cancer or interstitial lung disease
2. Pregnant or breastfeeding patients
3. Other patients who the principal investigator/researcher deems inappropriate as study subjects
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Fukumitsu |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
k-fkmt@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Fukumitsu |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
Homepage URL
k-fkmt@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital Allergy and Clinical Immunology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gamagori City Hospital, Sakura General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinival Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-858-7215
irb_jimu@med.nagoya-cu.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
| 2024 | Year | 11 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At the time of entry, and one, two, and three years later, a medical questionnaire is filled out, and chest CT scans, physiological tests, blood tests, etc. are also conducted. Capsaicin cough sensitivity tests are conducted at Nagoya City University Hospital, but not at Gamagori City Hospital and Sakura General Hospital. Induced sputum tests are conducted at Nagoya City University Hospital and Gamagori City Hospital, but not at Sakura General Hospital.
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063399
