Recruiting NCT06865040
Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Formoterol Fumarate 12 mcg (Foradil Aerolizer), Usual treatment.
- Who it may be relevant to
- Registry conditions: Thoracic Surgery, Postoperative Pulmonary Complications (PPCs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug 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. - Other Usual treatment
usual treatment
Primary outcome measures
- Number of postoperative pulmonary complication [Time frame: day 7]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHRU Amiens — Amiens
Identifiers
NCT: NCT06865040 · PI2023_843_0151