Evaluation of inhaled formoterol fumarate to prevent lung complications after chest cancer surgery in high-risk patients

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What is this study about?

This clinical trial focuses on studying postoperative pulmonary complications in patients undergoing thoracic surgery for lung cancer, specifically non-small-cell bronchopulmonary carcinoma. The study aims to evaluate whether using a breathing medication called formoterol fumarate, which belongs to a group of medications known as long-acting beta 2-selective adrenoceptor agonists, can help reduce breathing problems that may occur after chest surgery.

The treatment involves inhaling the medication, which helps open up the airways in the lungs to make breathing easier. The study will compare two groups of patients – one group receiving the breathing medication and another group not receiving it – to see if there is a difference in breathing complications that develop within 7 days after surgery.

Throughout the study, doctors will monitor patients’ breathing ability, heart function, and overall well-being. They will check for any side effects that might occur from the treatment, such as rapid heartbeat, headaches, or changes in blood sugar levels. The study will also track how patients are doing up to 6 months after their surgery to understand the long-term effects of the treatment.

1 Initial evaluation

You will undergo an evaluation to confirm your eligibility for lung cancer surgery

Your breathing capacity will be measured through a lung function test to confirm if you have less than 80% of normal lung function

You will be checked to ensure you are not currently using any long-term inhaler medications

2 Pre-surgery preparation

You may be assigned to receive formoterol, a medication that helps open your airways

The medication will be given through an inhaler device

If assigned to the medication group, you will start using the inhaler before surgery

3 Surgery and hospital stay

You will undergo the planned lung surgery

Your recovery will be monitored daily for the first 7 days

Daily checks will include monitoring for side effects such as dry mouth, headaches, rapid heartbeat, or changes in blood sugar levels

4 Follow-up at 7 days

Your lung function will be tested again using a portable breathing device

You will complete a quality of life questionnaire

The medical team will assess if you experienced any breathing complications

5 28-day follow-up

Another breathing test will be performed

Your overall health status will be checked

You will complete another quality of life questionnaire

6 6-month follow-up

A final quality of life assessment will be conducted by phone

This marks the completion of your participation in the study

Who Can Join the Study?

Must be at least 18 years old
Must have been diagnosed with lung cancer that can be treated with surgery (specifically non-small-cell lung cancer)
Must never have used long-term inhaler medications for breathing problems before
Must have reduced lung function with a breathing test result (FEV1) less than 80% of normal value. FEV1 measures how much air you can forcefully exhale in one second
Must have active health insurance coverage
Must be able to understand and sign an informed consent document, which explains the study details and patient rights
Can be either male or female

Who Cannot Join the Study?

Age below 18 years old
Previous history of severe allergic reactions to bronchodilators (medications that help open airways)
Current uncontrolled asthma or severe breathing problems
Pregnancy or breastfeeding
Having taken bronchodilator medications within 24 hours before surgery
Emergency surgery cases
Inability to perform breathing tests or follow study instructions
Having severe heart conditions that could be affected by bronchodilators
Current participation in other clinical trials
Known allergies to any components of the study medication
Having serious liver or kidney problems that might affect medication processing
History of adverse reactions to anesthesia
Mental conditions that could affect ability to provide informed consent

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.04.2024

Trial locations

Investigated drugs:

Formoterol Fumarate

Inhaled bronchodilator therapy is a treatment that helps open up the airways in the lungs. The medication is breathed in through an inhaler device. It works by relaxing the muscles around the airways, making it easier to breathe. This type of therapy is commonly used before and after thoracic surgery to help prevent breathing complications and improve lung function during the recovery period.

Investigated diseases:

Post procedural complication

Postoperative Pulmonary Complications (PPC) – A group of respiratory conditions that can develop after surgery, particularly following thoracic operations. These complications typically develop within the first week after surgery and may include atelectasis (collapsed air sacs in the lungs), pneumonia, bronchospasm, and abnormal breathing patterns. The condition affects lung function and can cause changes in breathing capacity, potentially leading to reduced oxygen levels. PPCs can vary in severity and may influence the recovery process after surgery.

Chronic Obstructive Pulmonary Disease (COPD) – A progressive lung disease characterized by persistent airflow limitation and breathing difficulties. The condition typically involves inflammation of the airways, damage to lung tissue, and narrowing of the breathing tubes. COPD causes symptoms such as shortness of breath, chronic cough, and increased mucus production. The disease develops gradually over time, often beginning with mild symptoms that worsen slowly.

Trial ID:

2023-510564-12-00

Protocol code:

PI2023_843_0151

Trial Phase:

Therapeutic confirmatory (Phase III)

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