search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


ABC-trial.


- candidate number0
- NTR NumberNTR351
- ISRCTNISRCTN10798392
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR22-jul-2005
- Secondary IDsP04-08 MEC
- Public TitleABC-trial.
- Scientific TitleThe effects of the use of antibiotics during acute exacerbations in COPD on the severity and duration of exacerbations: the ABC-trial.
- ACRONYMABC-trial
- hypothesisPrimary: Additional treatment with antibiotics in case of an exacerbation of 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.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), COPD
- Inclusion criteria1. Patients of the outpatient clinic of the Medical Spectrum Twente;
2. Age between 40 and 75;
3. A clinical diagnosis of COPD as defined by the 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: a positive Gram’s stain of the sputum, a clinical relevant decrease of lung function, defined as a decrease in FEV1 of 200 ml or more and 12 % or more from baseline value, or 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.
- Exclusion criteria1. Serious other disease with a low survival rate;
2. Clinical symptoms (e.g. temperature > 38,5 oC), 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, sarcoïdosis, pulmonary embolism, rib fracture, pneumonia and bronchial carcinoma);
4. Severe psychiatric illness;
* Uncontrolled diabetes mellitus;
5. Need for regular oxygen therapy;
6. Maintenance therapy with antibiotics;
7. Subject with a known hypersensitivity to amoxicillin / clavulanic acid (Augmentin®);
8. Use of antibiotic 4 weeks before study entry;
9. Use of prednisolon (except for a maintenance ration) 4 weeks before study entry;
10. An exacerbation less than 4 weeks before study entry;
11. alpha1-antitrypsine deficiency;
12. Former participation in the ABC-trial.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-mei-2005
- planned closingdate1-jan-2007
- Target number of participants60
- InterventionsIntervention group:
Prednisolon 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:
Prednisolon 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.
- Primary outcomeDuration of the exacerbations. This is measured by a Body Area Network, a symptom diary and lung function (FEV1 and PEF).
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. dr. J. Palen, van der
- CONTACT for SCIENTIFIC QUERIESMSc. M.G.J. Keizer
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
SENTER
- PublicationsN/A
- Brief summaryA randomised controlled study to investigate whether in a case of an exacerbation, additional treatment with antibiotics leads to a reduction in the severity and duration of exacerbations compared to treatment without antibiotics, in patients with COPD presenting one or two of the following characteristics: a positive Gram’s stain of the sputum, a clinical relevant decrease of lung function from the baseline or two or more exacerbations in the previous year. Furthermore we want to investigate whether the relapse rate is lower in case of treatment with antibiotics and prednisolon compared to treatment with prednisolon alone in these subjects. This study will include 60 COPD patients presenting with an exacerbation. The patients are randomly assigned to either the intervention group or the control group. Patients in the intervention will receive antibiotics and prednisolon and patients in the control group will receive a placebo and prednisolon. During the next 28 days all patients will have to complete a diary on a daily base, both an electronic diary, as well as an identical paper one. Furthermore, oxygen saturation, breathing rate, heart rate and temperature are collected with help of telemonitoring on a daily base. Lung function will be daily self-measured by use of a spirometer. Health related quality of life will be measured by the CCQ. Utilities during stable state and during an exacerbation will be measured with the EuroQol 5D.
- Main changes (audit trail)
- RECORD19-okt-2005 - 15-nov-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl
  • Dit zijn de gegevens waarmee uw trial is aangemeld en geregistreerd in het Nederlands Trial Register