Condition category
Respiratory
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
03/07/2009
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

Dr J. van der Palen

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR351; MEC: P04-08

Study information

Scientific title

Acronym

ABC-trial

Study hypothesis

Primary:
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

Ethics approval received from the local medical ethics committee

Study design

Double blinded, randomised, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Intervention 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 type

Drug

Phase

Not Specified

Drug names

Prednisolone, antibiotics (amoxicillin/clavulanic acid)

Primary outcome measures

Duration of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF).

Secondary outcome measures

1. 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 trial start date

25/05/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. 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

Recruitment start date

25/05/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medisch Spectrum Twente
Enschede
7500 KA
Netherlands

Sponsor information

Organisation

Medisch Spectrum Twente (Netherlands)

Sponsor details

P.O. Box 50000
Enschede
7500 KA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.mstwente.nl/

Funders

Funder type

Government

Funder name

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

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