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
Scientific
West China Hospital
Sichuan University
Respiratory Department
NO37 Outer-south
Guoxue Alley
Chengdu
610041
China
Study information
| Study design | Randomised placebo-controlled double-blind multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Please contact Miss Yufang Huang (loveflower404@163.com) to request a patient information sheet. |
| 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 |
| Study acronym | AAABC study |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 18/02/2009 |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/02/2009 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- China
Study participating centre
West China Hospital
Chengdu
610041
China
610041
China
Sponsor information
West China Hospital, Sichuan University (China)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Chuntao Liu
Respiratory Department
NO37 Outer-south
Guoxue Alley
Chengdu
610041
China
| Website | http://eng.cd120.com/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
