Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT01353235
Eligibility Criteria:
Inclusion Criteria:
* All COPD patients (according to the ATS definition) experiencing acute exacerbation originating in acute respiratory failure and requiring ICU admission will be included in the study.
COPD exacerbation is defined by the increased frequency of cough, volume and purulence of sputum and that of wheeze.
Acute respiratory failure is defined by the presence of hypercapnia with PaCO2 \>45mmHg associated with pH \> 7.35 and signs of respiratory muscle fatigue (contraction of accessory respiratory muscles, thoracoabdominal swinging ,..).
Exclusion Criteria:
* Asthmatic patients defined by a reversible obstructive disease following nebulized bronchodilators,
* Patients with uncontrolled left heart failure,
* AECOPD patients with a radiologically documented pneumonia,
* Systemic corticotherapy within 30 days before screening,
* contra-indication to corticosteroids (active gastroduodenal ulcer, uncontrolled sepsis, etc. ..)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01353235
Study Brief:
Protocol Section:
NCT01353235