Eosinophil-guided Reduction of Inhaled Corticosteroids

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid (ICS) therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD) receiving long-acting b-agonist (LABA) / long-acting muscarinic receptor antagonists (LAMA) / ICS treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• COPD (verified by a specialist in respiratory medicine + spirometry)

• Global Initiative for Obstructive Lung Disease (GOLD) risk class C/D or FEV1<30%

• Must receive at least during last 4 weeks: LAMA, LABA and ICS

• Informed consent

Exclusion Criteria:

• Known asthma

• Male <40 years

• Female<55 years

• Non-menopausal women>55 years (Had menstruation within the last 12 months)

• Non-eosinophil (blood eosinophil < 0.3 x 109 cells/L AND infiltrate on chest X-ray/c-reactive protein (CRP) >50 mg/L) exacerbation in the last 3 months

• Severe mental illness which considerably complicates co-operation

• Language problems that considerably complicate co-operation.

• Current treatment with systemic corticosteroids corresponding to >5 mg prednisolone per day

• Current treatment with antibiotics (For the subgroups participating in the microbiome study)

• Allergy to inhaled corticosteroids

• Contra-indication to treat with azithromycin( e.g. prolonged corrected QT interval (QTc) > 480 msec, interactions with other medications).