UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053404 |
|---|---|
| Receipt number | R000060941 |
| Scientific Title | A systematic review of the efficacy and safety of mucolytics in patients with stable chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2024/01/21 |
| Last modified on | 2024/01/21 12:09:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A systematic review of the efficacy and safety of mucolytics in patients with stable chronic obstructive pulmonary disease
Acronym
Mucolytics in patients with stable chronic obstructive pulmonary disease
Scientific Title
A systematic review of the efficacy and safety of mucolytics in patients with stable chronic obstructive pulmonary disease
Scientific Title:Acronym
Mucolytics in patients with stable chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease(COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of mucolytics in patients with stable COPD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COPD exacerbations
hospitalization
Key secondary outcomes
duration of antimicrobial therapy
duration of exacerbation
duration of disability
time to first exacerbation
St. George's Respiratory Questionnaire score
forced expiratory volume in one second
forced vital capacity
adverse events
serious adverse events
mortality
cost-effectiveness
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic obstructive pulmonary disease (COPD)
Key exclusion criteria
Subjects with chronic bronchitis without evidence of fixed airflow limitation (FEV1%<70)
Subjects started on mucolytics as a treatment for COPD exacerbations
Asthma and chronic obstructive pulmonary disease (COPD) overlap (ACO)
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | HIROSHI |
| Middle name | |
| Last name | OHNISHI |
Organization
Kochi Medical School, Kochi University
Division name
Department of Respiratory Medicine and Allergology
Zip code
780-8505
Address
Kohasu 185-1, Oko-cho, Nankoku, Kochi, 780-8505, Japan
TEL
088-880-2345
honi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROSHI |
| Middle name | |
| Last name | OHNISHI |
Organization
Kochi Medical School, Kochi University
Division name
Department of Respiratory Medicine and Allergology
Zip code
780-8505
Address
Kohasu 185-1, Oko-cho, Nankoku, Kochi, 780-8505, Japan
TEL
088-880-2345
Homepage URL
honi@kochi-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Allergology, Kochi Medical School, Kochi University
Institute
Department
Personal name
Hiroshi Ohnishi
Funding Source
Organization
None
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
Department of Respiratory Medicine and Allergology, Kochi Medical School, Kochi University
Address
Kohasu 185-1, Oko-cho, Nankoku, Kochi, 780-8505, Japan
Tel
088-880-2345
honi@kochi-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
| 2024 | Year | 01 | Month | 21 | 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
| 2023 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 27 | 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
Systematic review
Management information
Registered date
| 2024 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060941
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
