Efficacy of perioperative treatment intervention with ICS/LAMA/LABA combination inhalers in patients with malignant lung tumors comorbid with COPD:A prospective, open-label

JRCT ID: jRCT1031240636

Registered date:27/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with malignant lung tumors and COPD
• Date of first enrollment: 27/01/2025
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Inhaler therapy during the perioperative period

Outcome(s)

• Primary Outcome: The reduction in trough FEV1 from baseline levels at 12-24 weeks postoperatively

Secondary Outcome

[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).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Suzuki Hidemi
• Source(s) of Monetary Support: Chiba University Hospital