NCT06865040

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jul 2025Sep 2028

First Submitted

Initial submission to the registry

March 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

March 4, 2025

Last Update Submit

January 15, 2026

Conditions

Thoracic SurgeryPostoperative Pulmonary Complications (PPCs)

Keywords

Thoracic surgerypostoperative pulmonary complicationsInhaled therapybronchodilatorsB2 mimetics

Outcome Measures

Primary Outcomes (1)

  • Number of postoperative pulmonary complication

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

    day 7

Study Arms (2)

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.

Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer)

control group

SHAM COMPARATOR

The trial was conducted as an open-label study for the control group.

Other: Usual treatment

Interventions

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.

experimental group
Usual treatmentOTHER

usual treatment

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Interventions

Formoterol Fumarate

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Central Study Contacts

THOMAS LEFEBVRE, MD

CONTACT

33 + 322087889Lefebvre.Thomas@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 7, 2025

Study Start

July 31, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)