Bronchiectasis, Non-Cystic Fibrosis
Conditions
Brief summary
Bronchiectasis is a chronic respiratory disease characterized by recurrent infections, inflammation, and progressive lung damage. Frequent exacerbations are associated with increased morbidity, accelerated lung function decline, and reduced quality of life. Preventing exacerbations is a key therapeutic goal. Moxifloxacin, a fluoroquinolone antibiotic with broad-spectrum activity, may play a role in intermittent eradication therapy to reduce bacterial load, achieve microbiological clearance, and minimize exacerbation frequency. This randomized controlled trial will evaluate the effectiveness and safety of long-term intermittent moxifloxacin therapy compared with standard care in patients with non-cystic fibrosis bronchiectasis.
Interventions
DRUGIntermittent Moxifloxacin + Standard Care
Moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months), in addition to guideline-based standard care
OTHERStandard Care (in control arm)
Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years of age. * Confirmed diagnosis of non-cystic fibrosis bronchiectasis by high-resolution CT (HRCT). * History of ≥2 bronchiectasis exacerbations in the previous 12 months.
Exclusion criteria
* Diagnosis of cystic fibrosis-related bronchiectasis. * Known hypersensitivity or contraindication to fluoroquinolones (including moxifloxacin). * Severe hepatic impairment or severe renal impairment (eGFR \<30 mL/min/1.73 m²). * Pregnancy or breastfeeding. * History of significant QT prolongation, arrhythmia, or concurrent use of QT-prolonging drugs. * Use of long-term suppressive antibiotics for bronchiectasis in the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbation frequency | 12 months | Number of acute bronchiectasis exacerbations per patient during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological clearance | 12 months | Rate of clearance of Pseudomonas aeruginosa and other pathogens from sputum cultures |
| Change in FVC | Baseline and 12 months | Change in Forced vital capacity |
Countries
Egypt
Contacts
Primary Contactmontaser gamal ahmed, lecturer
Outcome results
None listed