Condition category
Respiratory
Date applied
04/02/2009
Date assigned
19/03/2009
Last edited
21/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chuntao Liu

ORCID ID

Contact details

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

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 measures

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

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

http://eng.cd120.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes