Additional antibiotics for acute bacterial exacerbation of chronic obstructive pulmonary disease

Completed

• Conditions: Acute bacterial exacerbations in chronic obstructive pulmonary disease (COPD); Respiratory; Other chronic obstructive pulmonary disease

• Registration Number: ISRCTN43262969
• Lead Sponsor: West China Hospital, Sichuan University (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following will be followed-up for one year:<br>1. Time to acute exacerbation <br>2. Incidence of total acute exacerbation

Secondary Outcome Measures

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