Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in patients at high risk of postoperative pulmonary complications

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

14 Aug 2025 → ongoing

Decision date (initial)

2024-10-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU Amiens

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare postoperative pulmonary complications (PPC) at D7 of thoracic surgery in groups with and without bronchodilator.

Secondary objectives 9

1. To describe the effect of the interaction between the bronchodilator/no bronchodilator group and the ARISCAT score on the occurrence of PPC at D7.
2. To describe the effect of the interaction between the group with/without bronchodilator and the presence or absence of COPD on the occurrence of PPC at D7
3. Describe the effect of the interaction between the bronchodilator/no bronchodilator group and long-term inhaled anticholinergic therapy on the occurrence of PPC at D7
4. Compare PPC at D28 of thoracic surgery in the bronchodilator and non-bronchodilator groups.
5. Compare lung volume at D7 and D28 of thoracic surgery in groups with and without bronchodilator
6. Compare major cardiovascular events at D28 of thoracic surgery in groups with and without bronchodilator
7. Compare mortality at D28 in the bronchodilator and non-bronchodilator groups.
8. Describe and compare quality of life at D7, D28 and 6 months after thoracic surgery in the bronchodilator and non-bronchodilator groups
9. Describe treatment-related adverse events

Conditions and MedDRA coding

postoperative pulmonary complications

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age > 18 years old
2. Lung cancer eligible for surgical lung resection (non-small-cell bronchopulmonary carcinoma = NSCLC) by any route.
3. Naïve to long-term inhaled bronchodilator therapy
4. High risk of post-operative pulmonary complications : at least one of the following criteria is met: • Preoperative FEV₁ < 80% of the predicted value, OR • DLCO < 80% of the predicted value (Diffusing Capacity of the Lung for Carbon Monoxide), OR • VO₂max < 20 ml/kg/min during a cardiopulmonary exercise test (CPET)
5. affiliation to health cover
6. Signed informed consent

Exclusion criteria 13

1. Emergency surgery
2. Patient with a physiological status classified WHO IV or ASA ≥ IV
3. Asthma
4. Patients treated with long-acting bronchodilators
5. Severe heart failure (NYHA IV), unstable ischemic heart disease (angina or recent infarction < 3 months)
6. Recent cerebrovascular accident (CVA) < 3 months
7. High-grade non-equipped conductive disorders or unstable arrhythmia
8. Thyrotoxicosis, pheochromocytoma
9. Unbalanced diabetes
10. Hypersensitivity to beta-2 mimetics
11. Pregnant, parturient or breast-feeding women
12. Patients under guardianship or private guardianship
13. Current participation in a trial of another drug therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. postoperative pulmonary complications (PPC) at D7 post thoracic surgery

Secondary endpoints 9

1. Post-operative pulmonary complications at D7 and interaction between group with/without bronchodilator and ARISCAT score
2. Post-operative pulmonary complications at D7 and interaction between the group with/without bronchodilator and the presence or absence of COPD.
3. Post-operative pulmonary complications at D7 and interaction between the bronchodilator/no bronchodilator group and long-term inhaled anticholinergic therapy
4. Post-operative pulmonary complications at D28 (assessed as for primary endpoint)
5. Pulmonary function by spirometry on D7 (or day of discharge if earlier) and D28 post-op (measured with the Spirolab® Spirometer validated for bed-side measurements: [including: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), Tiffeneau ratio = FEV1/FVCx 100, peak expiratory flow (PEF)] etc.).
6. Cardiovascular complications (cardiac arrhythmia, acute myocardial infarction according to the 4th universal definition, ischemic or hemorrhagic stroke) at D28 post-op.
7. Postoperative survival status
8. Quality of life assessed at D7 (or discharge), D28 and 6 months post-operatively using the standardized questionnaire [EuroQol-5D (EQ-5D)] via remote telephone cal
9. - Potential treatment-related adverse events (investigated daily in hospital): o Flushing o Dry mouth, dysgeusia o Headaches, tremors o Palpitations, atrial fibrillation, extrasystoles, tachycardia (> 100/min over 24h), prolonged QTc (> 450 ms in men and 470 ms in women) o Hypokalemia (< 3.5mmol/l) o Hyperglycemia (> 10 mmol/L)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

Sponsor organisation

Centre Hospitalier Universitaire Amiens Picardie

Address

1 Rond Point Du Pr Christian Cabrol

City

Amiens Cedex 1

Postcode

80054

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

lefebvre Thomas

Public contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

lefebvre Thomas

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications