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Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in patients at high risk of postoperative pulmonary complications
EU CTIS ID: 2023-510564-12-00
What this study is testing
To compare postoperative pulmonary complications (PPC) at D7 of thoracic surgery in groups with and without bronchodilator.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years old
- Lung cancer eligible for surgical lung resection (non-small-cell bronchopulmonary carcinoma = NSCLC) by any route.
- Naïve to long-term inhaled bronchodilator therapy
- High risk of post-operative pulmonary complications : at least one of the following criteria is met: • Preoperative FEV₁ < 80% of the predicted value, OR • DLCO < 80% of the predicted value (Diffusing Capacity of the Lung for Carbon Monoxide), OR • VO₂max < 20 ml/kg/min during a cardiopulmonary exercise test (CPET)
- affiliation to health cover
- Signed informed consent
You likely can't join if
- Emergency surgery
- Hypersensitivity to beta-2 mimetics
- Pregnant, parturient or breast-feeding women
- Patients under guardianship or private guardianship
- Current participation in a trial of another drug therapy
- Patient with a physiological status classified WHO IV or ASA ≥ IV
See the full eligibility criteria
- Age > 18 years old
- Lung cancer eligible for surgical lung resection (non-small-cell bronchopulmonary carcinoma = NSCLC) by any route.
- Naïve to long-term inhaled bronchodilator therapy
- High risk of post-operative pulmonary complications : at least one of the following criteria is met: • Preoperative FEV₁ < 80% of the predicted value, OR • DLCO < 80% of the predicted value (Diffusing Capacity of the Lung for Carbon Monoxide), OR • VO₂max < 20 ml/kg/min during a cardiopulmonary exercise test (CPET)
- affiliation to health cover
- Signed informed consent
- Emergency surgery
- Hypersensitivity to beta-2 mimetics
- Pregnant, parturient or breast-feeding women
- Patients under guardianship or private guardianship
- Current participation in a trial of another drug therapy
- Patient with a physiological status classified WHO IV or ASA ≥ IV
- Asthma
- Patients treated with long-acting bronchodilators
- Severe heart failure (NYHA IV), unstable ischemic heart disease (angina or recent infarction < 3 months)
- Recent cerebrovascular accident (CVA) < 3 months
- High-grade non-equipped conductive disorders or unstable arrhythmia
- Thyrotoxicosis, pheochromocytoma
- Unbalanced diabetes
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.