Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
AAABC study
Study hypothesis
Additional antibiotics administration in bacteria exacerbation of chronic obstructive pulmonary disease (COPD) inpatients after common antibiotics treatment will decrease the incidence of acute exacerbations by lowering the bacterial burden.
Ethics approval
Ethics Committee for Biomedical Research Projects, West China Hospital, Sichuan University, approved on 17/02/2009 (ref: NO 3, 2009)
Study design
Randomised placebo-controlled double-blind multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Please contact Miss Yufang Huang (loveflower404@163.com) to request a patient information sheet.
Condition
Acute bacterial exacerbations in chronic obstructive pulmonary disease (COPD)
Intervention
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 allocation.
As of 21/06/2010 this record has been updated to include an extended anticipated end date; the initial anticipated end date at the time of registration was 01/07/2010.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The following will be followed-up for one year:
1. Time to acute exacerbation
2. Incidence of total acute exacerbation
Secondary outcome measures
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)
Overall trial start date
18/02/2009
Overall trial end date
01/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
18/02/2009
Recruitment end date
01/07/2012
Locations
Countries of recruitment
China
Trial participating centre
West China Hospital
Chengdu
610041
China
Sponsor information
Organisation
West China Hospital, Sichuan University (China)
Sponsor details
c/o Prof Chuntao Liu
Respiratory Department
NO37 Outer-south
Guoxue Alley
Chengdu
610041
China
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bayer Health Care/ Bayer Schering Pharma (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list