UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057981 |
|---|---|
| Receipt number | R000066289 |
| Scientific Title | Relationships of upper airway changes during 6-second forced expiration with exertional variables in chronic obstructive pulmonary disease - a single-center, prospective, exploratory study |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2025/08/22 16:09:40 |
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Basic information
Public title
Relationships of upper airway changes with exertional variables of chronic obstructive pulmonary disease - a single-center, prospective, exploratory study
Acronym
Exertional variables and upper airway changes in chronic obstructive pulmonary disease
Scientific Title
Relationships of upper airway changes during 6-second forced expiration with exertional variables in chronic obstructive pulmonary disease - a single-center, prospective, exploratory study
Scientific Title:Acronym
Effects of upper airway changes on exertional variables in chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how upper airway, including the glottis, and central airway changes in the mediastinum during 6 seconds of forced expiration affect ventilation and exertional variables in COPD in a prospective, exploratory study.
Basic objectives2
Others
Basic objectives -Others
Physiologic elucidation of ventilatory limitation in COPD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between the degree of upper airway obstruction and one-second forced expiratory volume-related variables (%FEV1, FEV1, FEV1/FVC, PEF, PEF (V'25 V'50))
Key secondary outcomes
Correlations between the degree of upper airway obstruction and (1) resting pulmonary function variables other than those in the previous section, (2) cardiopulmonary exercise testing variables, (3) impedance values on oscillometry, (4) maximum inspiratory and expiratory muscle strength, and (5) subjective symptoms (CAT scores)
Correlations between the degree of central airway obstruction in the mediastinum and (1) resting pulmonary function variables, (2) cardiopulmonary exercise testing variables, (3) impedance values on oscillometry, (4) maximum inspiratory and expiratory muscle strength, and (5) subjective symptoms (CAT scores)
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
| 83 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with COPD, stage I-IV by the GOLD airflow limitation classification
2) Patients who are deemed stable by the physician and can be adequately evaluated by cardiopulmonary exercise testing (Stable as defined here is defined as no sudden worsening of symptoms such as cough, sputum, or dyspnea on exertion in COPD patients within 1 month retrospectively from the start of the study, and when the drug dose and drug content are constant.)
3) Patients who have given their written, informed consent
Key exclusion criteria
1) Patients with malignant tumors (patients with no recurrence 5 years after treatment are not excluded from the trial)
2) Patients with active infections
3) Patients with severe cardiac disease
4) Patients with bronchial asthma
5) Patients undergoing respiratory rehabilitation
6) Patients requiring FiO2 higher than 24% during cardiopulmonary exercise testing
7) Patients at obvious high risk for pneumothorax, such as a history of repeated pneumothorax, huge bullae,etc.
8) Other patients deemed inappropriate by the physician in charge
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Miki |
Organization
NHO Osaka Toneyama Medical Center
Division name
Laboratory of Respiratory Science, Division of Clinical Research
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL
06-6853-2001
miki.keisuke.pu@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Miki |
Organization
NHO Osaka Toneyama Medical Center
Division name
Laboratory of Respiratory Science, Division of Clinical Research
Zip code
56
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL
06-6853-2001
Homepage URL
410-chiken@mail.hosp.go.jp
Sponsor or person
Institute
NHO Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization (Incorporated Administrative Agency
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
The Clinical Research Review Board of NHO Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
Tel
06-6853-2001
410-chiken@mail.hosp.go.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
独立行政法人国立病院機構大阪刀根山医療センター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective exploratory study is being conducted at the NHO Osaka Toneyama Medical Center to determine how upper airway, including the glottis, and central airway changes in the mediastinum during 6 seconds of forced expiration affect ventilation and exertional variables in COPD.
Management information
Registered date
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066289
