RecruitingNot ApplicableNCT06865040
Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
266 participants
Start Date
Jul 31, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The objective of the study is to evaluate, in a clinical trial, the efficacy of peri operative administration of long-acting inhaled ß-2 mimetics on the occurrence of postoperative pulmonary complications
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria12
- 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
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Interventions
DRUGFormoterol Fumarate 12 mcg (Foradil Aerolizer)
Administration in the interventional arm of long-acting inhaled ß-2 mimetics: FORMOTEROL FUMARATE 12 µg pwd inhalation capsule (FORMOTEROL VIATRIS®), taken twice a day intraoperatively from Day-2 to Day 7.
OTHERUsual treatment
usual treatment
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06865040
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