STOP-COPD Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

The primary objective of this study is to evaluate whether a prehospital **titrated oxygen** strategy in patients with suspected Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) can decrease 30-day mortality compared to standard care. This is clinically relevant as reducing mortality in AECOPD patients can significantly improve patient outcomes and reduce healthcare burdens.

Secondary objectives include:

• Determining if the titrated oxygen strategy positively affects experienced dyspnoea, rated on a scale from 0-10, compared to standard care.
• Assessing whether this strategy reduces the in-hospital need for non-invasive ventilation (NIV) or invasive ventilation.
• Evaluating if there is a reduction in 24-hour and 7-day mortality rates.
• Investigating whether the strategy decreases the proportion of patients with respiratory acidosis and the degree of acidosis upon hospital arrival.
• Analyzing if the strategy reduces mortality, acidosis, ICU admission rates, and the need for assisted ventilation based on prehospital transport time.
• Determining differences in time to intensive care admission, non-invasive ventilation, or endotracheal assisted ventilation events.
• Assessing if the strategy lowers the readmission rate compared to standard care.

The clinical trial focuses on individuals experiencing **Acute Exacerbation of Chronic Obstructive Pulmonary Disease** (AECOPD). The study population includes both male and female participants, aged 40 years and older. The trial does not specify the total number of participants, as the sponsor has not provided this information. Participants were selected based on the suspicion of AECOPD by treating emergency medical technicians or paramedics. The trial includes a vulnerable population, although specific lifestyle considerations such as diet, physical activity, or habits are not detailed. Key inclusion criteria involve patients over the age of 40 with suspected AECOPD, while exclusion criteria are not explicitly mentioned.

The clinical trial is designed to evaluate the efficacy of prehospital titrated oxygen therapy in patients with suspected **acute exacerbation of chronic obstructive pulmonary disease** (AECOPD) compared to standard care. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the healthcare providers know which treatment the participants are receiving, thus minimizing bias. The trial is expected to run from January 2023 to May 2026, with the primary endpoint being the reduction in 30-day mortality. Secondary endpoints include 24-hour and 7-day mortality, length of hospitalization, ICU admission rate, and various measures of respiratory function and patient experience.

Participants will be involved in the study for a maximum treatment period of one day, with the possibility of early termination if they no longer meet the inclusion criteria or if adverse events occur. The study begins with a screening visit to confirm eligibility, which includes patients over the age of 40 years suspected of having an AECOPD by an EMT or paramedic. Follow-up visits will be conducted to monitor the participants' health status and collect data on the primary and secondary endpoints. The end-of-study visit will occur after the completion of the treatment period to assess the final outcomes and gather any remaining data.

The investigational products used in the trial include **salbutamol sulfate**, **oxygen**, **air, medicinal**, and a combination of **fenoterol hydrobromide** and **ipratropium bromide**, all administered via inhalation. These products are used in accordance with their marketing authorizations, classifying the trial as low-intervention. The trial's design and methodology are structured to ensure the collection of reliable and valid data, contributing to the understanding of the potential benefits of targeted oxygen therapy in the management of AECOPD.

The clinical trial involves the administration of several treatments, including **Salbutamol** "TEVA", a nebuliser solution containing **salbutamol sulfate** as the active ingredient. This medication is administered via **inhalation** using a nebuliser. The maximum daily dose is 25 mg, with a total treatment period of one day. The solution is provided by TEVA B.V and is not a paediatric formulation. Participant compliance is monitored through the administration process.

Another treatment used in the trial is **Conoxia 100%**, a compressed medicinal gas containing **oxygen**. This gas is also administered via inhalation, with a maximum daily dose of 1000 litres. The treatment period is limited to one day. The product is supplied by LINDE GAS and is not formulated for paediatric use. Compliance is ensured by monitoring the inhalation process.

**AIRAPY** is another compressed medicinal gas used in the study, consisting of **medicinal air**. It is administered through inhalation, with a maximum daily dose of 1000 litres and a treatment period of one day. This product is also provided by LINDE GAS and is not intended for paediatric use. Participant adherence is tracked through the inhalation administration.

The trial also includes the use of **Berodual**, a nebuliser solution containing **fenoterol hydrobromide** and **ipratropium bromide**. This solution is administered via inhalation, with a maximum daily dose of 6.25 mg over a one-day treatment period. The product is manufactured by BOEHRINGER INGELHEIM INTERNATIONAL GMBH and is not a paediatric formulation. Compliance is monitored through the inhalation process.

The efficacy of the clinical trial titled "STOP-COPD Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease" will be assessed using both primary and secondary endpoints. The primary endpoint is the **30-day mortality** rate, which will be used to determine the effectiveness of prehospital titrated oxygen therapy compared to standard care in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Secondary endpoints include 24-hour mortality, 7-day mortality, length of hospitalization, ICU admission rate, length of ICU admission, in-hospital need for non-invasive ventilation, time to non-invasive ventilation, in-hospital need for invasive ventilation, time to invasive ventilation, proportion of patients with respiratory acidosis on arrival to hospital, the degree of acidosis based on the pH-value, patient-experienced dyspnoea on a verbal rating scale of 0-10, and readmission rate.