Additional antibiotics for acute bacterial exacerbation of chronic obstructive pulmonary disease

ISRCTN ISRCTN43262969
DOI https://doi.org/10.1186/ISRCTN43262969
Secondary identifying numbers N/A
Submission date
04/02/2009
Registration date
19/03/2009
Last edited
21/06/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Chuntao Liu
Scientific

West China Hospital
Sichuan University
Respiratory Department
NO37 Outer-south
Guoxue Alley
Chengdu
610041
China

Study information

Study designRandomised placebo-controlled double-blind multi-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Please contact Miss Yufang Huang (loveflower404@163.com) to request a patient information sheet.
Scientific titleRandomised, 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
Study acronymAAABC study
Study objectivesAdditional 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(s)Ethics Committee for Biomedical Research Projects, West China Hospital, Sichuan University, approved on 17/02/2009 (ref: NO 3, 2009)
Health condition(s) or problem(s) studiedAcute bacterial exacerbations in chronic obstructive pulmonary disease (COPD)
InterventionIntervention 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 typeOther
Primary outcome measureThe following will be followed-up for one year:
1. Time to acute exacerbation
2. Incidence of total acute exacerbation
Secondary outcome measuresThe 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 study start date18/02/2009
Completion date01/07/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/02/2009
Date of final enrolment01/07/2012

Locations

Countries of recruitment

  • China

Study participating centre

West China Hospital
Chengdu
610041
China

Sponsor information

West China Hospital, Sichuan University (China)
Hospital/treatment centre

c/o Prof Chuntao Liu
Respiratory Department
NO37 Outer-south
Guoxue Alley
Chengdu
610041
China

Website http://eng.cd120.com/
ROR logo "ROR" https://ror.org/007mrxy13

Funders

Funder type

Other

Investigator initiated and funded (China)

No information available

Bayer Health Care/ Bayer Schering Pharma (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan