Asthma
Conditions
Interventions
Azithromycin at 250mg daily for 48 weeks
Sponsors
Saga University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed to asthma whose age are more than 20 years old were included. All of the patients were more than 25 kg/m2 of BMI and experienced one or more times of moderate or severe exacerbation in previous year of the participant of present study. All of the patients should be obtained agreement for participation of present study on written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria will be: patients whose aspartate aminotransferase or alanine aminotransferase at more than 100 IU/L, creatinine at 2.0 mg/dL, who have life threatened arrhythmia or paroxysmal tachycardia at more than 100 times per minute of heart rate, who had been admitted by acute myocardial infarction or heart failure in previous year, who diagnosed malignancy in previous 5 years except for complete remission after the treatment, who treated by macrolide antibiotics in previous 4 week and biologics including omalizumab, mepolizumab, benralizumab, dupilumab in previous 8 weeks at initiation of the intervention of azithromycin in present study, whose QT interval requires correction for heart rate at more than 480 ms, who are pregnant or under breastfeeding, whose BMI at less than 25 kg/m2, and who decided ineligible for present study by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is reduction of exacerbation rate after intervention of azithromycin for 48 weeks compared to that before the intervention. Here, the asthma exacerbation rate is defined as proportion of cases with asthma exacerbation after treatment among the analyzed cases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are differences of clinical and laboratory parameters between before and after intervention of azithromycin including blood eosinophil ratio, eosinophil count, IgE, pulmonary functions such as vital capacity (VC), forced vital capacity (FVC), %VC, forced expiratory volume in one second (FEV1), FEV1%, %FEV1, and body weight, BMI, level of fractional exhaled nitric oxide (FeNO), scores of asthma control test. Another secondary endpoints are to clarify the characteristics of frequency for asthma exacerbation in improving/non-improving patients, and the diversity indexes of gut microbiome including Chao 1, Shannon, Simpson index. For other exploratory endpoints, height, bodyweight, BMI and tendency of attenuation effect for exacerbation are assessed at the time point of 24 weeks of the intervention of azithromycin. Additionally, biomarkers including cytokines, chemokines, short chain fatty acids, metabolomics and species of gut microbiome are compared between before and after intervention of azithromycin, and examined for relationships between the alteration and exacerbation at 48 weeks. | — |
Countries
Japan
Contacts
Public ContactHiroki Tashiro
Saga University Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty
Outcome results
None listed