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

NCT ID: NCT06865040

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2028-09-30

Brief Summary

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

Conditions

Thoracic Surgery; Postoperative Pulmonary Complications (PPCs)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

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.

Group Type: EXPERIMENTAL

Formoterol Fumarate 12 mcg (Foradil Aerolizer)

Intervention Type: 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.

control group

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

Group Type: SHAM_COMPARATOR

Usual treatment

Intervention Type: OTHER

usual treatment

Interventions

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.

Intervention Type: DRUG

Usual treatment

usual treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Amiens

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

THOMAS LEFEBVRE, MD

Role: CONTACT

Lefebvre.Thomas@chu-amiens.fr

33 + 322087889

Facility Contacts

THOMAS LEFEBVRE, MD

Role: primary

Lefebvre.Thomas@chu-amiens.fr

33+322087889

Other Identifiers

PI2023_843_0151

Identifier Type: -

Identifier Source: org_study_id