Thoracic SurgeryTICTACNCT06865040
Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
A study testing Formoterol Fumarate 12 mcg (Foradil Aerolizer) and Usual treatment in people with Thoracic Surgery and Postoperative Pulmonary Complications (PPCs), run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- Formoterol Fumarate 12 mcg (Foradil Aerolizer) and Usual treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2025to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- Patient refusal
- Pregnancy
- Emergency surgery
- Patient with a physiological status of WHO IV or ASA ≥ IV
- Asthma
- Patients treated with long-acting bronchodilators
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens, 80054
THOMAS LEFEBVRE, MD, 33+322087889, Lefebvre.Thomas@chu-amiens.fr
Osama ABOU ARAB, Pr
About this study
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
- Being tested
- Formoterol Fumarate 12 mcg (Foradil Aerolizer), Usual treatment
- Keywords
- Thoracic surgery, postoperative pulmonary complications, Inhaled therapy, bronchodilators, B2 mimetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 treatmentOther
usual treatment
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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. Receives: Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer) |
| control group | Sham comparator | The trial was conducted as an open-label study for the control group. Receives: Other: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of postoperative pulmonary complication
Number of postoperative pulmonary complications (PPC) at day 7 after a thoracic surgery for lung resection
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start31 Jul 2025
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865040
- Sponsor's protocol ID
- PI2023_843_0151
- Acronym
- TICTAC
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No