Perioperative long-acting inhaled bronchodilator for lung cancer surgery patients at high risk of postoperative lung complications
Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
This trial will test whether giving a long-acting inhaled bronchodilator (formoterol) around the time of lung cancer surgery helps reduce postoperative lung complications in adults with reduced lung function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06865040 on ClinicalTrials.gov |
What this trial studies
Adults with non-small cell lung cancer scheduled for lung resection and a preoperative FEV1 below 80% who are naïve to long-term inhaled bronchodilators are enrolled. Participants receive perioperative formoterol inhalation in addition to usual care or usual care alone, and are followed for occurrence of postoperative pulmonary complications. Key exclusions include asthma, recent cardiovascular events, severe uncontrolled cardiac disease, current long-acting bronchodilator use, pregnancy, emergency surgery, and WHO/ASA class IV patients. The main outcome is the rate of postoperative pulmonary complications within the perioperative period.
Who should consider this trial
Good fit: Ideal participants are adults with resectable NSCLC scheduled for lung resection who have preoperative FEV1 < 80% and are not already on long-acting inhaled bronchodilators.
Not a fit: Patients with asthma, severe or unstable cardiac disease, those already treated with long-acting bronchodilators, or those with normal preoperative lung function are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, perioperative inhaled formoterol could reduce the frequency and severity of postoperative pulmonary complications and related length of hospital stay for high-risk lung surgery patients.
How similar studies have performed: Perioperative use of bronchodilators to prevent postoperative pulmonary complications has limited and mixed evidence, so this application in lung cancer surgery remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years) * Lung cancer eligible for surgical management by lung resection (non-small cell lung carcinoma = NSCLC) by any route * Naïve to long-term inhaled bronchodilator therapy * High risk of post-operative pulmonary complications (Pre-operative FEV1 \< 80%) Exclusion Criteria: * Patient refusal * Pregnancy * Emergency surgery * Patient with a physiological status of WHO IV or ASA ≥ IV * Asthma * Patients treated with long-acting bronchodilators * Severe heart failure (NYHA IV), unstable ischaemic heart disease (angina or recent infarction \< 3 months), obstructive hypertrophic cardiomyopathy, subvalvular aortic stenosis, severe uncontrolled hypertension Recent stroke \< 3 months * High-grade unresponsive conductive disorders or unstable arrhythmia * Thyrotoxicosis, pheochromocytoma * Unbalanced diabetes * Hypersensitivity to ß-2 mimetics or lactose * Current participation in a trial of another drug therapy
Where this trial is running
Amiens
- CHRU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Thomas Lefebvre, Md
- Email: Lefebvre.Thomas@chu-amiens.fr
- Phone: 33 + 322087889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.