Not yet recruiting

Study on Oxygen Therapy and Salbutamol for Patients with COPD Exacerbation

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Chronic Obstructive Pulmonary Disease (COPD), specifically during an acute worsening of symptoms known as an acute exacerbation. The study aims to compare two different approaches to oxygen therapy provided before reaching the hospital. The treatments being tested include standard oxygen therapy and a more targeted approach where the amount of oxygen is carefully adjusted. The main goal is to find out if the targeted oxygen therapy can reduce the risk of death within 30 days compared to the standard method.

Participants in the study will receive one of the treatments through inhalation. The medications involved in the trial include Salbutamol, a solution used in nebulizers to help open the airways, and Berodual, which contains a combination of two substances, Fenoterol Hydrobromide and Ipratropium Bromide, also used to ease breathing. Additionally, Conoxia, a compressed medicinal gas containing pure Oxygen, and Airapy, a compressed medicinal gas, are part of the study. These treatments are administered to help manage breathing difficulties associated with COPD.

The study will monitor participants over a period to assess various outcomes, including the length of hospital stay, the need for intensive care, and the requirement for additional breathing support. The trial will also evaluate how patients feel in terms of breathlessness and other related symptoms. The study is expected to continue until 2026, with the aim of improving the understanding and management of COPD during acute episodes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose, which is to determine if prehospital titrated oxygen can reduce 30-day mortality in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) compared to standard care.
You will be asked to provide consent to participate in the study, acknowledging that you understand the trial's objectives and procedures.
Step 2
Initial assessment
A healthcare professional, such as an EMT or paramedic, will assess your condition to confirm if you are experiencing an acute exacerbation of chronic obstructive pulmonary disease.
This assessment will determine your eligibility to continue in the trial.
Step 3
Treatment administration
If eligible, you will receive treatment through inhalation. The medications used may include salbutamol sulfate, oxygen, air, medicinal, and a combination of fenoterol hydrobromide and ipratropium bromide.
The specific medication, dosage, and frequency will be determined by the healthcare provider based on your condition and the trial protocol.
Step 4
Monitoring and follow-up
Throughout the trial, your health will be closely monitored to assess the effectiveness of the treatment and any side effects.
You may be required to visit the hospital or clinic for follow-up assessments at specified intervals.
Step 5
Completion of trial
The trial will conclude on the estimated end date of May 1, 2026, or when the necessary data has been collected.
You will be informed about the results of the trial and any implications for your ongoing care.

Who can join the trial?

3 criteria

The treating emergency medical technician (EMT) or paramedic thinks you have an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This means a sudden worsening of your lung condition.
You are over the age of 40 years.
Both men and women can participate.

Who cannot join the trial?

4 criteria

Patients who are not experiencing an acute exacerbation of chronic obstructive pulmonary disease (COPD). An acute exacerbation is a sudden worsening of COPD symptoms.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of the vulnerable population selected for the study.

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Investigated drugs

Oxygen Therapy is a treatment that provides extra oxygen to people who have trouble breathing. In this trial, oxygen therapy is used to help patients with Chronic Obstructive Pulmonary Disease (COPD) who are experiencing a sudden worsening of their symptoms. The goal is to see if adjusting the amount of oxygen given to each patient can help reduce the risk of death within 30 days compared to the usual way oxygen is given.

What is already known about the treatment

Oxygen Therapy – Oxygen therapy is administered through a mask or nasal prongs to help patients with breathing difficulties, particularly those experiencing an acute exacerbation of chronic obstructive pulmonary disease (COPD). It is currently a well-established treatment in medical practice and literature, especially for managing COPD symptoms. The main therapeutic indication is to improve oxygen levels in the blood, which can help reduce shortness of breath and improve overall respiratory function. At the molecular level, oxygen therapy works by increasing the amount of oxygen available to the lungs and bloodstream, which is crucial for cellular metabolism and energy production. It is classified as a respiratory therapy and is a critical component of emergency and long-term care for patients with severe respiratory conditions.

Investigated diseases

Acute Exacerbation of Chronic Obstructive Pulmonary Disease – This condition involves a sudden worsening of symptoms in individuals with Chronic Obstructive Pulmonary Disease (COPD). It is characterized by increased breathlessness, coughing, and production of sputum. The exacerbation can be triggered by infections or environmental pollutants. During an acute exacerbation, the airways become more inflamed and narrowed, leading to difficulty in breathing. Patients may experience increased fatigue and reduced ability to perform daily activities. The progression of symptoms can vary, with some individuals experiencing mild episodes and others facing more severe challenges.