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

Thoracic Surgery Postoperative Pulmonary Complications (PPCs)

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