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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06865040
Acronym
TICTAC
Enrollment
266
Registered
2025-03-07
Start date
2025-07-31
Completion date
2028-09-01
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pulmonary Complications (PPCs), Thoracic Surgery

Keywords

Thoracic surgery, postoperative pulmonary complications, Inhaled therapy, bronchodilators, B2 mimetics

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

Interventions

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.

OTHERUsual treatment

usual treatment

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

France

Contacts

CONTACTTHOMAS LEFEBVRE, MD
Lefebvre.Thomas@chu-amiens.fr33 + 322087889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026