Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients At High Risk of Postoperative Pulmonary Complications

Not Applicable

Not yet recruiting

• Conditions: Thoracic Surgery; Postoperative Pulmonary Complications (PPCs)
• Interventions: Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer); Other: Usual treatment

• Registration Number: NCT06865040
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-04
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2028-03
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Formoterol 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.
control group	Usual treatment	The trial was conducted as an open-label study for the control group.

Primary Outcome Measures

Name	Time	Method
Number of postoperative pulmonary complication	day 7	Number of postoperative pulmonary complications (PPC) at day 7 after a thoracic surgery for lung resection

Trial Locations

Locations (1)

CHRU Amiens; 🇫🇷 Amiens, France