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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT06865040
- Acronym / sponsor ID
- TICTAC / PI2023_843_0151
- Keywords
- Thoracic surgery, postoperative pulmonary complications, Inhaled therapy, bronchodilators, B2 mimetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: 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. |
| control group | Sham comparator | Other: Usual treatmentThe trial was conducted as an open-label study for the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%)
Key exclusion criteria (12 listed)
- Patient refusal
- Pregnancy
- Emergency surgery
- Patient with a physiological status of WHO IV or ASA ≥ IV
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | experimental group |
| Usual treatmentusual treatment | Other | control group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact THOMAS LEFEBVRE, MD (33 + 322087889, Lefebvre.Thomas@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of postoperative pulmonary complication (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.