A randomized controlled study of comparing the effect of two azithromycin regimens in reducing exacerbation of non-cystic fibrosis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052906

Enrollment

Unknown

Registered

2021-11-06

Start date

2022-01-01

Completion date

Unknown

Last updated

2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Interventions

Daily Azithromycin Group:Azithromycin 250mg QD

Weekly Azithromycin Group:Azithromycin 500mg TIW

Placebo Group:None

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and above; 2. Bronchiectasis confirmed by HRCT; 3. The patient had at least one acute exacerbation requiring antibiotics in the past 1 year.

Exclusion criteria

Exclusion criteria: 1. Cystic pulmonary fibrosis; 2. There is evidence of non-tuberculous mycobacteria infection in the past 2 years; 3. Bronchopulmonary aspergillosis; 4. Pregnant women, pregnant women, and breastfeeding women; 5. Abnormal liver function; 6. Severe arrhythmia; 7. Macrolide antibiotics used for more than 3 months in the past 6 months.

Design outcomes

Primary

Measure	Time frame
protocol-defined pulmonary exacerbation (PDPE) at 6 months;	—

Secondary

Measure	Time frame
time to first exacerbation;protocol-defined pulmonary exacerbation (PDPE) at 12 months;mMRC at 6 months;CAT at 6 months;Adverse effect;	—

Countries

China

Contacts

Public ContactFu Wenjiang

The First People' Hospital of Jiashan

fwjtjh168@sina.com+86 15967395738

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026