Actively Recruiting
Perioperative Inhaled Therapy in Carcinological Thoracic Surgery for Patients at High Risk of Postoperative Pulmonary Complications
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-01-16
266
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of giving long-acting inhaled beta-2 mimetics around the time of surgery to reduce the risk of lung complications after thoracic cancer surgery. The study focuses on adults undergoing lung cancer surgery who are at high risk for postoperative pulmonary complications due to reduced lung function. This clinical trial aims to understand if this inhaled therapy can help improve recovery after surgery. The study includes two groups: one group receives the inhaled drug Formoterol Fumarate 12 mcg twice daily from two days before surgery until seven days after surgery. The other group receives usual treatment without this inhaled therapy. The trial is open-label, meaning both patients and researchers know which treatment is given. Participants will be monitored for lung complications during the first week after surgery, with the main outcome measured at day 7. Researchers will assess the number of postoperative pulmonary complications to evaluate the treatment's impact. The study starts from screening and treatment days around surgery and follows participants through the immediate postoperative period until day 7.
CONDITIONS
Brief Title
Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Lung cancer eligible for surgical lung resection by any route
- No prior long-term inhaled bronchodilator therapy
- High risk of postoperative pulmonary complications with pre-operative FEV1 less than 80%
You will not qualify if you...
- Patient refusal to participate
- Pregnancy
- Emergency surgery cases
- Physiological status WHO IV or ASA score 4 or higher
- Asthma diagnosis
- Current treatment with long-acting bronchodilators
- Severe heart failure (NYHA IV) or unstable ischemic heart disease within 3 months
- Obstructive hypertrophic cardiomyopathy or subvalvular aortic stenosis
- Severe uncontrolled hypertension
- Recent stroke within 3 months
- High-grade unresponsive conductive heart disorders or unstable arrhythmia
- Thyrotoxicosis or pheochromocytoma
- Unbalanced diabetes
- Allergy to beta-2 mimetics or lactose
- Current participation in another drug trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 2 days before surgery to 7 days after surgery
Participants receive inhaled Formoterol Fumarate twice a day from 2 days before surgery until 7 days after surgery. Participants in the control group receive usual treatment without inhaled therapy.
Daily visits during treatment period
Trial Site Locations
Total: 1 location
1
CHRU Amiens
Amiens, France, 80054
Actively Recruiting
Research Team
T
THOMAS LEFEBVRE, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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