Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients At High Risk of Postoperative Pulmonary Complications (TICTAC)

Centre Hospitalier Universitaire, Amiens

Status: Not yet enrolling

Conditions: Postoperative Pulmonary Complications (PPCs); Thoracic Surgery

Treatments: Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer); Other: Usual treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06865040

PI2023_843_0151

Details and patient eligibility

About

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

Enrollment: 266 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer)

control group

Sham Comparator group

Description:

The trial was conducted as an open-label study for the control group.

Treatment:

Other: Usual treatment