Relationships of upper airway changes with exertional variables of chronic obstructive pulmonary disease - a single-center, prospective, exploratory study

Relationships of upper airway changes during 6-second forced expiration with exertional variables in chronic obstructive pulmonary disease - a single-center, prospective, exploratory study - Effects of upper airway changes on exertional variables in chronic obstructive pulmonary disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057981

Enrollment

Registered

2025-05-27

Start date

2025-05-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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))	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactKeisuke Miki

NHO Osaka Toneyama Medical Center Laboratory of Respiratory Science, Division of Clinical Research

410-chiken@mail.hosp.go.jp06-6853-2001

Outcome results