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

ConditionsThoracic Surgery Postoperative Pulmonary Complications (PPCs)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%)

Disqualifiers

Patient refusal

Pregnancy

Emergency surgery

Patient with a physiological status of WHO IV or ASA ≥ IV

Trial design

Design model

Parallel

Treatments tested in this trial

Formoterol Fumarate 12 mcg (Foradil Aerolizer)
Drug
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.
Usual treatment
Other intervention
usual treatment

Treatment groups

266 Participants

are divided into 2 treatment groups

Group A: experimental groupExperimental treatment 1 intervention

Group B: control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Number of postoperative pulmonary complication

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

Time frame

day 7

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Source ClinicalTrials.gov

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