A Phase 4 interventional study of Azithromycin and ICS in COPD, Inhaled Corticosteroid and Azithromycin, sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark. Completed at 9 sites in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Phase 4, Interventional, and Treatment
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.
Inhaled corticosteroid (ICS) treatment is recommended by Global Initiative for Obstructive Lung Disease (GOLD) for patients with frequent and/or servere exacerbations and blood eosinophils > 0.3 x 10\^9 cells/L and in those with ≥ 0,1 x 109 cells blood-eosinophils and recurrent exacerbations while on bronchodilators. ICS treatment, however, is associated with side effects such as diabetes, osteoporosis and pneumonia which is costly for both patients and society. By studying the effects of a personalized, eoseosinophil-guided approach to direct ICS in COPD patients with frequent AECOPDs through a randomized clinical trial this study will examine the possibilities of reducing ICS overtreatment and thus ICS-related adverse events.
Long term ICS treatment is known for affecting the bacterial load in stable COPD patients. Azithromycin exerts multiple effects on the structure and composition of the lower airway microbiota and has anti-inflammatory effects. This study will, moreover, investigate whether an oral low-dose prophylactic treatment with Azithromycin 250 mg three times weekly can reduce the number of moderate-severe AECOPD and improves time alive and out of hospital.
This study is a randomized, double-blinded, multicentre, four-arm intervention clinical trial and is conducted based on the principles of good clinical practise (GCP).
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 444 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Chronic Obstructive Pulmonary Disease Trial Network, Denmark is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Azithromycin: patients are given placebo 2. ICS: The patients are given the usual LAMA/LABA/ICS product in the usual dose.
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.
Drug: ICS
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
Drug: Azithromycin
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):
Drug: Azithromycin · Drug: ICS
Prophylactic azithromycin treatment 250 mg three times weekly vs placebo
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) vs continued LABA/LAMA/ICS treatment
Exacerbations, hospital and death
Number of hospitalization-requiring exacerbations within 12 months and/or death within 365 days
Time frame: 365 days
Days alive, out of hospital
Days alive and out of hospital within 365 days after recruitment
Time frame: 365 days
Deaths, uncontrolled AECOPD
Death or uncontrolled AECOPD tendency within 365 days
Time frame: 365 days
Number of exacerbations
Number of moderate/severe exacerbation within 365 days
Time frame: 365 days
Cumulative ICS dose
Cumulative dose of inhaled corticosteroids within 365 days
Time frame: 365 days
Cumulative OCS dose
Cumulative dose of systemic corticosteroids within 365 days
Time frame: 365 days
Change in FEV1
Change in lung function (ΔFEV1) from baseline to 365 days
Time frame: 365 days
Change in blood eosinophils
Change in blood eosinophils from baseline to 365 days (eosinophilic trajectories)
Time frame: 365 days
Diabetes mellitus
New diagnosis of diabetes mellitus within 365 days
Time frame: 365 days
Change in HbA1c
Change in HbA1c from baseline to 365 days
Time frame: 365 days
Number of antibiotic requiring infections
Antibiotic-requiring infections within 365 days
Time frame: 365 days
Microbiota, abundance and diversity
Difference in respiratory microbiota abundance and diversity from baseline to 12 months between treatment arms
Time frame: 365 days
Microbiota, immunological profile
Difference in immunological profile including cytokines and chemokines in the upper airways from baseline to 12 months between treatment arms
Time frame: 365 days
Change in CAT score
Change in COPD-related quality of life (Based on COPD Assessment Test - CAT) from baseline to 365 days
Time frame: 365 days
Change in MRC dyspnoea score
Number who progress to MRC -dyspnea score from \< 3 to ≥3 anytime during follow-up (assessed every 3 months).
Time frame: 365 days
Number of non-invasive ventilation (NIV) or intensive care admissions or death
Number of admission requiring non-invasive ventilation (NIV) treatment or admissions to intensive care within 365 days
Time frame: 365 days
Mortality
Mortality within 365 days
Time frame: 365 days
Plan to share: Undecided
Ran from Jun 2021 to primary completion in Nov 2024, 40 months.
Of 86 non-industry phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's 40 months is above that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
Pulmonary Disease, Chronic Obstructive →
Chronic Obstructive Pulmonary Disease Trial Network, Denmark