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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Præhospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2022-09-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

The Nationwide Emergency Medical Helicopter Service (Denmark)

External identifiers

EU CT number

2022-500816-21-00

WHO UTN

U1111-1278-2162

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine whether prehospital titrated oxygen in patients with suspected AECOPD will decrease 30-day mortality compared to patients receiving standard care.

Secondary objectives 7

1. • To determine whether a prehospital titrated oxygen strategy for AECOPD patients will have a positive effect on experienced dyspnoea, rated on a scale from 0-10 compared to patients receiving standard care
2. • To determine whether a prehospital titrated oxygen strategy for AECOPD patients will reduce the in-hospital need for NIV or invasive ventilation compared to patients receiving standard care
3. • To determine whether a prehospital titrated oxygen strategy for AECOPD patients will result in a reduced 24-hour and 7-day mortality compared to patients receiving standard care.
4. • To determine whether a prehospital titrated oxygen strategy for AECOPD patients will reduce the proportion of patients with respiratory acidosis (PaCO2 >6,3 kPa AND pH <7,35[6]) and the degree of acidosis measured on arrival to hospital compared to patients receiving standard care.
5. • To determine whether a prehospital titrated oxygen strategy for AECOPD patients reduces mortality (24 hours, 7 days, 30 days), acidosis, intensive care unit (ICU) admission rate and need of assisted ventilation compared to patients receiving standard care analyzed on a subgroup level based on prehospital transport time.
6. • To determine if there is a difference in time to intensive care admission, non-invasive ventilation or endotracheal assisted ventilation events
7. • To determine if a titrated oxygen strategy will lower the readmission rate compared with standard care

Conditions and MedDRA coding

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Treating EMT or Paramedic suspects acute exacerbation of chronic obstructive pulmonary disease
2. Patients over the age of 40 years

Exclusion criteria 7

1. Non-COPD bronchospasm
2. Known or suspected pregnancy
3. Prehospital NIV, invasive or bag mask assisted ventilation
4. Allergy to inhalation drug (Salbutamol)
5. Transfer between hospitals
6. More than 2 doses (5 mg salbutamol) inhalation drug, given by EMT or paramedic (acute treatment), before allocated treatment is initiated
7. Readmission within 30 days from last randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 30-day mortality

Secondary endpoints 13

1. 24-hour mortality
2. 7-day mortality
3. Length of hospitalization
4. ICU admission rate
5. Length of ICU admission
6. In-hospital need for non-invasive ventilation
7. Time to non-invasive ventilation
8. In-hospital need for invasive ventilation
9. Time to invasive ventilation
10. Proportion of patients with respiratory acidosis on arrival to hospital
11. The degree of acidosis based on the pH-value
12. Patient experienced dyspnoea on a verbal rating scale 0-10
13. Readmission rate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Præhospitalet

Sponsor organisation

Præhospitalet

Address

Olof Palmes Allé 34

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Præhospitalet

Contact name

Martin Fauerholt Gude

Public contact point

Organisation

Præhospitalet

Contact name

Martin Fauerholt Gude

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications