Clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD)

Phase 1

• Conditions: Clinicaltrial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD); MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2020-003014-12-DK
• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-09
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

•COPD (verified by a specialist in respiratory medicine + spirometry).
•GOLD risk class C/D 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%.
•Must receive at least during last 4 weeks: LAMA, LABA and ICS.
•Informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

•Known asthma
•Male <40 years
•Female <40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine HCG test
•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.
•Systemic antibiotic treatment or systemic corticosteroid treatment within 14 days (also prophylactic Azithromycin).
•Contra-indication to treat with Azithromycin (as listed by the producer).
•Non-bacterial exacerbation per investigator judgement in the last 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified