The effects of the use of antibiotics during acute exacerbations in chronic obstructive pulmonary disease (COPD) on the severity and duration of exacerbations: the ABC-trial

ISRCTN ISRCTN10798392
DOI https://doi.org/10.1186/ISRCTN10798392
Secondary identifying numbers NTR351; MEC: P04-08
Submission date
19/12/2005
Registration date
19/12/2005
Last edited
11/07/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. van der Palen
Scientific

Medisch Spectrum Twente
P.O. Box 50000
Enschede
7500 KA
Netherlands

Study information

Study designDouble blinded, randomised, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effects of the use of antibiotics during acute exacerbations in chronic obstructive pulmonary disease (COPD) on the severity and duration of exacerbations: the ABC-trial
Study acronymABC-trial
Study objectivesPrimary:
Additional treatment with antibiotics in case of an exacerbation of chronic obstructive pulmonary disease (COPD) will not lead to a reduction in the severity and duration of exacerbations compared to treatment without antibiotics.

Secondary:
The relapse rate (defined as a new exacerbations within 28 days) is not reduced in case of additional treatment with antibiotics of a COPD exacerbation.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD)
InterventionIntervention group: Prednisolone 30 mg for 7 days, antibiotics (Amoxicillin/clavulanic acid three times daily for 7 days) and a Body Area Network for monitoring of health status.
Control group: Prednisolone 30 mg for 7 days, placebo of Amoxicillin/clavulanic acid (three times daily for 7 days) and a Body Area Network for monitoring of health status.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Prednisolone, antibiotics (amoxicillin/clavulanic acid)
Primary outcome measureDuration of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF).
Secondary outcome measures1. Severity of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF).
2. Relapse rate. A relapse is defined as an exacerbation that resolves due to the blinded treatment but re-occurs within 28 days of the treated exacerbation.
3. Cost-effectiveness of treatment with antibiotics
4. Use of rescue-medication, recorded in the symptom diary
5. Quality of life, measured by the Chronic Respiratory Questionnaire and the COPD Chronic Questionnaire
Overall study start date25/05/2005
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Total final enrolment35
Key inclusion criteria1. Patients of the outpatient clinic of the Medical Spectrum Twente
2. Aged between 40 and 75 years
3. A clinical diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
4. A signed and dated written informed consent from the subject prior to study participation
5. Patients with COPD presenting one or two of the following characteristics:
5.1. A positive Gram’s stain of the sputum
5.2. A clinically relevant decrease of lung function, defined as a decrease in forced expiratory volume in one second (FEV1) of 200 ml or more and 12% or more from baseline value
5.3. Two or more exacerbations in the previous year
6. Present with signs and symptoms of an exacerbation at the outpatient clinic
7. Current smoker or ex-smoker
8. Able to understand, read and write Dutch
Key exclusion criteria1. Serious other disease with a low survival rate
2. Clinical symptoms (e.g. temperature greater than 38.5°C), indicating pneumonia and a thorax X-ray positive for pneumonia
3. Another disease, which influences bronchial symptoms and/or lung function (e.g. cardiac insufficiency, sarcoidosis, pulmonary embolism, rib fracture, pneumonia and bronchial carcinoma)
4. Severe psychiatric illness
5. Uncontrolled diabetes mellitus
6. Need for regular oxygen therapy
7. Maintenance therapy with antibiotics
8. Subject with a known hypersensitivity to amoxicillin/clavulanic acid (Augmentin®)
9. Use of antibiotic 4 weeks before study entry
10. Use of prednisolone (except for a maintenance ration) 4 weeks before study entry
11. An exacerbation less than 4 weeks before study entry
12. Alpha1-antitrypsine deficiency
13. Former participation in the ABC-trial
Date of first enrolment25/05/2005
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Medisch Spectrum Twente
Enschede
7500 KA
Netherlands

Sponsor information

Medisch Spectrum Twente (Netherlands)
Hospital/treatment centre

P.O. Box 50000
Enschede
7500 KA
Netherlands

http://www.mstwente.nl/
ROR logo https://ror.org/033xvax87

Funders

Funder type

Government

SENTER - A branch of the Dutch Ministry of Economic Affairs (Netherlands)

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 30/12/2014 11/07/2019 Yes No

Editorial Notes

11/07/2019: Publication reference and total final enrolment added.

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