Anti-viral Effects of Azithromycin in Patients With Asthma and COPD (NCT04319705) | Clinical Trial Compass
UnknownPhase 4
Anti-viral Effects of Azithromycin in Patients With Asthma and COPD
Denmark100 participantsStarted 2020-03-02
Plain-language summary
The purpose of this study is to investigate the anti-viral effects of low-dose AZM treatment in patients with asthma and COPD with an exacerbation history.
The investigators expect that long-term treatment with low dose AZM modulates the immune response to viral infections, with an increased interferon release, in patients with asthma and COPD with an exacerbation history. In addition, the investigators expect a decrease in inflammatory cells and mediators, and changes in bacteria, measured in samples from the lungs.
Half of the participants will receive azithromycin on top of their regular asthma/COPD treatment, while the other half will receive placebo on top of their regular asthma/COPD treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Diagnosis of asthma according to GINA, with confirmed variable airflow obstruction at screening visit or previously.
✓. Age ≥ 18 through 75 years.
✓. A postbronchodilator FEV1 ≥ 50% predicted
✓. Maintenance treatment with ICS and ≥ 1 second controller (LABA, LAMA, LTRA or Xanthines) for at least three months prior to Visit 1.
✕. Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (e.g., hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.
✕. Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., cystic fibrosis, pulmonary fibrosis, moderate-severe bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, active tuberculosis). In addition for the different groups the following:
✕. Patient with asthma: concomitant COPD.
✕. Patients with COPD: concomitant asthma (former and current)
✕. Healthy subjects: COPD and asthma.
✕. Any clinically relevant abnormal findings in hematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
✕. Evidence of active liver disease, including jaundice or aspartate transaminase, alanine transaminase, or alkaline phosphatase \>1.5 times the upper limit of normal (laboratory results from Visit 1).