Eosinophil-guided Reduction of Inhaled Corticosteroids
Who is this study for? Patients with Chronic Obstructive Pulmonary Disease
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• COPD (verified by a specialist in respiratory medicine + spirometry)
• GOLD class E anytime within the last 2 years (corresponding to 2 ≥ AECOPD and/or ≥1 AECOPD leading to hospitalization during a 12 months period within the last 2 years) and/or FEV1\<30%.
• Treatment for last 4 weeks including LAMA, LABA and ICS
• Informed consent
Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Hvidovre Hospital
RECRUITING
Copenhagen
Sydvestjysk Sygehus Esbjerg
RECRUITING
Esbjerg
Gentofte Hospital
RECRUITING
Hellerup
Nordsjællands Hospital
RECRUITING
Hillerød
Næstved-Slagelse-Ringsted Sygehus
RECRUITING
Næstved
Odense University Hospital
RECRUITING
Odense
Roskilde Sygehus
RECRUITING
Roskilde
Silkeborg Sygehus
RECRUITING
Silkeborg
Contact Information
Primary
Jens-Ulrik Jensen
jens.ulrik.jensen@regionh.dk
38673057
Time Frame
Start Date: 2021-06-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 444
Treatments
No_intervention: Eosinophil_Control/Azithro_Control
1. Azithromycin: patients are given placebo~2. ICS: The patients are given the usual LAMA/LABA/ICS product in the usual dose.
Experimental: Eosinophil_Active/Azithro_Control:
a. Azithromycin: placebo b. ICS: All patients will receive LABA/LAMA medication. The ICS medication will be switched on/off according to the most recent blood eosinophil count (at inclusion + every 3 months): i. If blood eosinophil ≥ 300 cells/μL, ICS in usual dose next 3 months. Blood eosinophils are measured every 3 months.~ii. If blood eosinophil \<300 cells/μL, ICS is discontinued.
Experimental: Eosinophil_Control/Azithro_Active group
Azithromycin: 250 mg azithromycin three times weekly. b. ICS: The patients are given the usual LAMA/LABA/ICS product in the usual dose, where the medical treatment for severe COPD is unchanged throughout the entire project period
Experimental: Eosinophil_Active/Azithro_Active:
1. Azithromycin: 250 mg azithromycin three times weekly.~2. ICS: All patients will receive LABA/LAMA medication. The ICS medication will be switched on/off according to the most recent blood eosinophil count (at inclusion + every 3 months):
Related Therapeutic Areas
Sponsors
Leads: Chronic Obstructive Pulmonary Disease Trial Network, Denmark