Additional antibiotics for acute bacterial exacerbation of chronic obstructive pulmonary disease

Randomised, double-blind, multi-centre, placebo-controlled study to evaluate the efficacy of 6-day additional oral moxifloxacin administration 400 mg once a day (qd) after common antibiotic treatment on acute bacterial exacerbation of chronic obstructive pulmonary disease patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43262969

Enrollment

Registered

2009-03-19

Start date

2009-02-18

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Acute bacterial exacerbations in chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

Intervention group: Moxifloxacin (oral) 400 mg once a day (qd) for 6 days Control group: Placebo Subjects, caregivers, investigators and outcomes assessors will all be blinded to the treatment alloca

the initial anticipated end date at the time of registration was 01/07/2010.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, 45-80 years old 2. History of COPD (Global Initiative for chronic Obstructive Lung Disease [GOLD] 2006 criteria) 3. Moderate to severe COPD (GOLD 2006 criteria) 4. Have at least one acute exacerbation episodes in the proceeding year 5. Clinical evidence of acute bacteria exacerbations of COPD. Patient must meet criterion 5.1 below plus one of the other four criteria to be eligible: 5.1. Production of purulent sputum as defined by gramistained sputum specimen 5.2. Increased dyspnoea 5.3. Increased sputum production 5.4. Fever 5.5. Increased white blood cells (WBC) or neutrophilic granulocyte portion

Exclusion criteria

Exclusion criteria: 1. Extremely severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) 2. Comply with pulmonary encephalopathy 3. Heart failure,acute cornary artery syndrome 4. Gastrointestimal (GI) bleeding 5. Need for mechanical ventilation 6. History of hypersensitivity to fluoroquinolones 7. Creatinine (Cr) >=1 x upper limit of normal (ULN), blood urea nitrogen (BUN) >=1 x ULN, aspartate aminotransferase (AST), alanine aminotransferase (ALT) >= 5 x ULN or total bilirubin >=3 x ULN at screening 8. Other chronic respiratory disease that lead to decline in pulmonary function, such as pneumonia, cancer, asthma, bronchiectasis, diffused lung interstitial fibrosis 9. Infection that is not because of pulmonary or bronchial tree 10. Use of systemic glucocorticoid (prednisolone >10 mg/d or other corticoid equal to this) within 30 days

Design outcomes

Primary

Measure	Time frame
The following will be followed-up for one year: 1. Time to acute exacerbation 2. Incidence of total acute exacerbation	—

Secondary

Measure	Time frame
The following will be assessed at 14 and 30 days from end of interventions, then every two months for one year: 1. Changes in lung function (Forced expiratory volume in 1 second [FEV1], FEV1/Forced vital capacity [FVC]) 2. The BODE index: Body Mass Index(B), Airflow obstruction (O), Dyspnoea(D), Exercise capacity index(E)	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026