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Study on Oxygen Therapy and Drug Combination for Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

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 effects of different oxygen therapies for patients experiencing an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD). AECOPD is a sudden worsening of symptoms in people with Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes it hard to breathe. The study will compare two types of oxygen therapy: standard oxygen therapy and targeted oxygen therapy, which is adjusted based on the patient's needs before they reach the hospital.

The purpose of the study is to find out if using targeted oxygen therapy can reduce the risk of death within 30 days compared to standard care. Participants in the study will receive one of the oxygen therapies, and some may also receive medications like Berodual (containing fenoterol hydrobromide and ipratropium bromide), Salbutamol, or Medicinal Oxygen to help with breathing. These treatments are given through inhalation, which means they are breathed in using a device called a nebulizer or as a compressed gas.

The study will follow participants over a period to monitor their health outcomes, such as survival rates at different time points, the length of hospital stays, and the need for additional breathing support like non-invasive ventilation (NIV) or mechanical ventilation. The goal is to improve the care and outcomes for patients with AECOPD by determining the most effective oxygen therapy approach.

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, the patient 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.
The patient will be required to provide consent to participate in the study after understanding the potential risks and benefits.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm the suspicion of chronic obstructive pulmonary disease (COPD) and the need for inhaled bronchodilators.
Eligibility criteria include being over the age of 40 and having a treating emergency medical technician (EMT) or paramedic suspect AECOPD.
Step 3
Treatment administration
The patient will receive treatment through inhalation. The medications used include fenoterol hydrobromide and ipratropium bromide as a nebuliser solution, salbutamol sulfate as a nebuliser solution, and oxygen or medicinal air as compressed medicinal gas.
The frequency and dosage of these medications will be determined by the medical team based on the patient's condition and response to treatment.
Step 4
Monitoring and follow-up
The patient's condition will be monitored throughout the trial to assess the effectiveness of the treatment. This includes tracking mortality rates at 24 hours, 7 days, and 30 days, as well as other health indicators such as the need for intensive care unit (ICU) admission and the occurrence of respiratory acidosis.
The patient will be asked to report any symptoms or side effects experienced during the trial.
Step 5
Completion of trial
At the end of the trial, the patient will undergo a final assessment to evaluate the overall impact of the treatment on their health.
The results of the trial will contribute to understanding the best practices for managing AECOPD in prehospital settings.

Who can join the trial?

4 criteria

Confirmed suspicion of COPD (Chronic Obstructive Pulmonary Disease)
The treating EMT (Emergency Medical Technician) or Paramedic suspects AECOPD (Acute Exacerbation of Chronic Obstructive Pulmonary Disease)
Patients over the age of 40 years
Need of inhaled bronchodilators (medications that help open the airways in the lungs)

Who cannot join the trial?

4 criteria

Patients who are not experiencing an acute exacerbation of chronic obstructive pulmonary disease (COPD) cannot participate. An acute exacerbation is a sudden worsening of COPD symptoms.
Patients who are not within the specified age range for the study cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial group cannot participate. This group includes both males and females.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes individuals who may have difficulty giving informed consent or are at higher risk of harm.

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Investigated drugs

Oxygen Therapy is a treatment that provides extra oxygen to people who have trouble breathing. In this clinical trial, oxygen therapy is used in two different ways to help patients with Chronic Obstructive Pulmonary Disease (COPD). The first way is the standard method, where patients receive a fixed amount of oxygen. The second way is a targeted method, where the amount of oxygen is adjusted based on the patient's needs. The goal is to see if adjusting the oxygen levels can help reduce the risk of death within 30 days for patients experiencing a worsening of their COPD symptoms.

What is already known about the treatment

Oxygen Therapy – Oxygen therapy is administered through a mask or nasal cannula to help patients with breathing difficulties, such as those experiencing an acute exacerbation of chronic obstructive pulmonary disease (COPD). It is a well-established treatment in medical practice and literature, primarily used to increase oxygen levels in the blood. The main therapeutic indication for oxygen therapy in this context is to manage and alleviate symptoms of COPD exacerbations. At the molecular level, oxygen therapy works by increasing the amount of oxygen available to the lungs, which then gets absorbed into the bloodstream, helping to improve overall oxygenation in the body. It is classified as a respiratory therapy and is crucial for patients with compromised lung function.

Investigated diseases

Acute Exacerbation of Chronic Obstructive Pulmonary Disease – This condition is a sudden worsening of symptoms in individuals with Chronic Obstructive Pulmonary Disease (COPD). It is characterized by an increase in breathlessness, coughing, and the production of sputum. The exacerbation can be triggered by infections, environmental pollutants, or other factors. During an acute exacerbation, the airways become more inflamed and narrowed, leading to difficulty in breathing. The progression involves increased respiratory distress and may require medical intervention to manage symptoms. The condition can lead to further complications if not addressed promptly.