Formoterol fumarate for Postoperative pulmonary complications

Inclusion criteria

• {"criterion_text":"- Age > 18 years old"}
• {"criterion_text":"- Lung cancer eligible for surgical lung resection (non-small-cell bronchopulmonary carcinoma = NSCLC) by any route."}
• {"criterion_text":"- Naïve to long-term inhaled bronchodilator therapy"}
• {"criterion_text":"- High risk of post-operative pulmonary complications : at least one of the following criteria is met: •\tPreoperative FEV₁ < 80% of the predicted value, OR •\tDLCO < 80% of the predicted value (Diffusing Capacity of the Lung for Carbon Monoxide), OR •\tVO₂max < 20 ml/kg/min during a cardiopulmonary exercise test (CPET)"}
• {"criterion_text":"- affiliation to health cover"}
• {"criterion_text":"- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Emergency surgery"}
• {"criterion_text":"- Hypersensitivity to beta-2 mimetics"}
• {"criterion_text":"- Pregnant, parturient or breast-feeding women"}
• {"criterion_text":"- Patients under guardianship or private guardianship"}
• {"criterion_text":"- Current participation in a trial of another drug therapy"}
• {"criterion_text":"- Patient with a physiological status classified WHO IV or ASA ≥ IV"}
• {"criterion_text":"- Asthma"}
• {"criterion_text":"- Patients treated with long-acting bronchodilators"}
• {"criterion_text":"- Severe heart failure (NYHA IV), unstable ischemic heart disease (angina or recent infarction < 3 months)"}
• {"criterion_text":"- Recent cerebrovascular accident (CVA) < 3 months"}
• {"criterion_text":"- High-grade non-equipped conductive disorders or unstable arrhythmia"}
• {"criterion_text":"- Thyrotoxicosis, pheochromocytoma"}
• {"criterion_text":"- Unbalanced diabetes"}

Primary endpoints

• {"endpoint_text":"- postoperative pulmonary complications (PPC) at D7 post thoracic surgery","definition_or_measurement_approach":"Considered present within 7 days after surgery if at least one postoperative pulmonary complication (PPC) occurs, defined according to standard European (EPCO) definitions."}

Secondary endpoints

• {"endpoint_text":"- Post-operative pulmonary complications at D7 and interaction between group with/without bronchodilator and ARISCAT score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Post-operative pulmonary complications at D7 and interaction between the group with/without bronchodilator and the presence or absence of COPD.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Post-operative pulmonary complications at D7 and interaction between the bronchodilator/no bronchodilator group and long-term inhaled anticholinergic therapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Post-operative pulmonary complications at D28 (assessed as for primary endpoint)","definition_or_measurement_approach":"Assessed using the same criteria as the primary endpoint (PPC definitions as per EPCO) at day 28 post-op."}
• {"endpoint_text":"- Pulmonary function by spirometry on D7 (or day of discharge if earlier) and D28 post-op (measured with the Spirolab® Spirometer validated for bed-side measurements: [including: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), Tiffeneau ratio = FEV1/FVCx 100, peak expiratory flow (PEF)] etc.).","definition_or_measurement_approach":"Spirometry measurements (FEV1, FVC, FEV1/FVC %, PEF) using Spirolab® Spirometer at D7 (or discharge if earlier) and D28."}
• {"endpoint_text":"- Cardiovascular complications (cardiac arrhythmia, acute myocardial infarction according to the 4th universal definition, ischemic or hemorrhagic stroke) at D28 post-op.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Postoperative survival status","definition_or_measurement_approach":"Survival status (alive/deceased) assessed at D28 post-op."}
• {"endpoint_text":"- Quality of life assessed at D7 (or discharge), D28 and 6 months post-operatively using the standardized questionnaire [EuroQol-5D (EQ-5D)] via remote telephone cal","definition_or_measurement_approach":"Quality of life measured using EQ-5D questionnaire administered via remote telephone call at D7 (or discharge), D28 and 6 months."}
• {"endpoint_text":"- Potential treatment-related adverse events (investigated daily in hospital): o Flushing o Dry mouth, dysgeusia o Headaches, tremors o Palpitations, atrial fibrillation, extrasystoles, tachycardia (> 100/min over 24h), prolonged QTc (> 450 ms in men and 470 ms in women) o Hypokalemia (< 3.5mmol/l) o Hyperglycemia (> 10 mmol/L)","definition_or_measurement_approach":"Treatment-related adverse events monitored daily during hospitalization; specific events as listed will be investigated and recorded (including ECG/QTc, serum potassium, glucose measurements)."}

France

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

15-10-2024

Processing Time Days

5

Number Of Sites

1

Number Of Participants

266

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France