BACE Trial Substudy 1 - PROactive Substudy

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A first sub-analysis of the BACE trial will address physical activity levels in a subgroup of the intervention study with portable validated activity monitors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wim Janssens
• Collaborator: Pro-Active Medical Pty Ltd
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)

• Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)

• Current hospitalization for potential infectious AECOPD treated with standard therapy

• History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken

• ECG at admission

Exclusion Criteria:

• Mechanical or non-invasive ventilation at moment of randomization (D1)

• Long QT interval on ECG (QTc > 450msec for males or > 470msec for females)

• History of life-threatening arrhythmias

• Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug

• Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission

• Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)

• Documented uncorrected severe hypokalemia (K+ < 3.0 mmol/L) or hypomagnesemia (Mg2+ < 0.5 mmol/L)

• Chronic systemic steroids (> 4 mg methylprednisolone /day for ≥ 2 months)

• Actual use of macrolides for at least 2 weeks

• Allergy to macrolides

• Active cancer treatment

• Life expectancy < 3 months

• Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment