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]

Trial duration

11 Dec 2024 → ongoing

Decision date (initial)

2022-12-06

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Region Midtjyllands Strategiske Forskningsmidler · Simon Spies Fonden · The Nationwide Emergency Medical Helicopter Service (Denmark) · Eva Merete Falck Crones Fond

External identifiers

EU CT number

2022-502003-30-00

WHO UTN

U1111-1278-2162

ClinicalTrials.gov

NCT05703919

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 8

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) 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 whether a titrated oxygen strategy has an effect on time to intensive care admission, non-invasive ventilation or endotracheal assisted ventilation events compared with standard care
7. • To determine if a titrated oxygen strategy will lower the readmission rate compared with standard care
8. To determine whether a prehospital titrated oxygen strategy for patients with AECOPD will result in reduced length of hospital and ICU stay compared with patients receiving 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 4

1. Confirmed suspicion of COPD
2. The treating EMT or Paramedic suspects AECOPD
3. Patients over the age of 40 years
4. Need of inhaled bronchodilators

Exclusion criteria 9

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, acute treatment by EMS personnel, before allocated treatment is initiated
7. Readmission within 30 days from last randomization
8. Suspicion of acute coronary syndrome (ACS)
9. Prior decline to participate in the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 30-day mortality

Secondary endpoints 14

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 NIV within 24 hours, 7 days and 30 days
7. Time to NIV
8. In-hospital need for invasive mechanical ventilation within 24 hours, 7 days and 30 days
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
14. Time to readmission

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 Faurholt Gude

Public contact point

Organisation

Præhospitalet

Contact name

Martin Faurholt Gude

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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