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NCT Number: NCT06865040

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

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

Recruiting

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Key information

Conditions

Thoracic Surgery Postoperative Pulmonary Complications (PPCs)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, 80054, France

Location status: Recruiting

Location contact

Florence DE DOMINICIS, MD

SUB_INVESTIGATOR

Osama ABOU ARAB, Pr

SUB_INVESTIGATOR

THOMAS LEFEBVRE, MD

CONTACT

[email protected]

33+322087889

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

usual treatment

Primary outcomes

  1. Number of postoperative pulmonary complication

    Time frame: day 7

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

Study contacts

Contact information is provided by the study sponsor or research team.

THOMAS LEFEBVRE, MD

CONTACT

[email protected]

33 + 322087889

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: TICTAC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 7, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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