Reducing effect of azithromycin for exacerbation in asthma patients who experiencing exacerbation: focusing on their body mass index

JRCT ID: jRCTs071220023

Registered date:29/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bronchial Asthma
• Date of first enrollment: 29/06/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Azythromycin 250mg, 1 time per day for 48 weeks

Outcome(s)

• Primary Outcome: Differences of asthma exacerbation rate between those before and 48 weeks after administration of azythromycin.

Secondary Outcome

1) The changes in following variables between those before and 48 weeks after administration of azythromycin.
a) Blood IgE level
b) Blood eosinophil ratio and eosinophil count.
c) Vital capacity (VC), %VC, Forced VC, Forced Expiratory Volume in one second (FEV1.0), FEV1.0%, %FEV1.0.
d) Weight, BMI
e) FeNO
f) Score of asthma control test
2) Relationship between exacerbation count until 48 weeks after administration of azythromycin and presence of exacerbation.
3) Diversity of gut microbiome (Chao 1 index, Shannon index, Simpson index)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Asthma patients who have a history of the exacerbation in the past year, whose ages are from 20 and whose BMI are more than 25. Gender do not matter.
2) Patients who have been confirmed the diagnosis of asthma based on GINA guidelines: respiratory symptoms that are characteristic of asthma plus or minus wheeze, and clinical improvement (improvement of asthma symptoms and / or increase in FEV1 of >12% and >200 mL) by asthma treatment (ICS-LABA).
3) Patients provided written informed consent to participate in this study.

Exclude criteria

1) Patients with serious hepatic dysfunction (serum AST or ALT >=100 IU/L), or renal dysfunction (BUN >=25 mg/dL or serum Cr >=2 mg/dL) at the time of registration.
2) Patients with paroxysmal tachycardia (more than 100 times / min) or life-threatening arrhythmia at the time of registration.
3) Patients with a history of myocardial infarction in the past year, or a history of hospitalization for heart failure in the past year.
4) Patients with a history of malignant tumor (except for basal cell carcinoma, squamous cell carcinoma, gastrointestinal malignant tumor, and only endoscopic mucosal resection) within the past 5 years (except for patients whose ECOG PS 0 is used and there is no problem with walking at the time of registration by the discretion of a specialist, and who is expected that there will be no recurrence of cancer requiring treatment during the period of participation in this study).
5) Patients who treated by macrolide antibiotics within 4 weeks before intervention day.
6) Patients who treated by biological agents within 8 weeks before intervention day.
7) Patients whose QTc are more than 480ms on electrocardiogram at the time of registration.
8) Patients who are pregnant or under lactating.
9) Patients whose BMI are less than 25.
10) Other patients who are judged to be inappropriate by the principal investigator or the investigator.

Related Information

• Primary Sponsor: Tashiro Hiroki
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology