Perioperative long-acting inhaled bronchodilator for lung cancer surgery patients at high risk of postoperative lung complications
Official title: Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
Run by Centre Hospitalier Universitaire, Amiens · NCT06865040 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 266 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | July 31, 2025 |
| Main results expected | March 2028 |
| Study ends | September 2028 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT06865040 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Perioperative use of bronchodilators to prevent postoperative pulmonary complications has limited and mixed evidence, so this application in lung cancer surgery remains relatively novel.
Who can join: the full rules
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 it's running
-
CHRU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Thomas Lefebvre, Md
- Email: Lefebvre.Thomas@chu-amiens.fr
- Phone: 33 + 322087889
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.