Patients with malignant lung tumors and COPD lung malignant tumor, COPD
Conditions
Interventions
Inhaler therapy during the perioperative period
lung malignant tumor, COPD, surgery, inhaler intervention
Sponsors
Suzuki Hidemi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be included: Adults aged 18 years or older at the time of consent acquisition. Patients with a forced expiratory volume in 1 second (FEV1) of less than 70% as measured by pulmonary function testing. Patients diagnosed with pulmonary malignancy based on pathological examination, or those with suspected pulmonary malignancy based on imaging studies. Patients scheduled for anatomical lung resection (lobectomy or segmentectomy) for pulmonary lesions. Patients who have not undergone initial therapeutic intervention for COPD. Patients who have received a full explanation about this study, fully understand it, and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: The following individuals will be excluded from the study: Patients with a history of chronic respiratory diseases other than asthma or COPD, or a recent history of respiratory infections. Patients requiring continuous oxygen therapy or currently taking corticosteroids. Patients for whom inhalation therapy is contraindicated. Patients who are pregnant, potentially pregnant, within 28 days postpartum, or breastfeeding. Patients deemed unsuitable for safe participation in this study by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction in trough FEV1 from baseline levels at 12-24 weeks postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| [Secondary Efficacy Endpoints] 1) Reduction in FVC from baseline level 2) COPD Assessment Test (CAT) score 3) mMRC (Medical Research Council dyspnea scale) 4) Number of emergency visits due to respiratory symptoms [Secondary Safety Endpoints] Incidence of adverse events, side effects, serious side effects, and postoperative complications (including new-onset pneumonia and arrhythmia). | — |
Contacts
Public ContactDaiki Shimizu
Chiba University Hospital
Outcome results
None listed