Antibiotics for exacerbations of chronic obstructive pulmonary disease

• Research type

  Research Study

• Full title

  Antibiotics for exacerbations of chronic obstructive pulmonary disease: a pilot randomised trial within the General Practice Research Database

• IRAS ID

  50189

• Contact name

  Tjeerd-Pieter van Staa

• Sponsor organisation

  London School of Hygiene & Tropical Medicine

• Eudract number

  2010-019513-24

• ISRCTN Number

  ISRCTN72035428

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterised by continuous shortness of breath. Subjects with COPD frequently suffer from acute exacerbations of the disease, characterised by an increase in symptoms of dyspnoea, sputum volume or with green sputum. COPD subjects with green sputum are currently treated with a course of antibiotics. But there is not much evidence whether to treat COPD subjects who do not (yet) have green sputum. This proposal wants to evaluate whether it is possible for general practitioners to conduct a study that compares antibiotics with usual care. This information will be based on information that is already routinely collected in the NHS. As an example, when patients are admitted to a hospital, the disease causing the hospitalisation is recorded in order to help the administration of the NHS and the patient??s GP is informed about the hospitalisation. This kind of routinely collected information will be used in this proposal. Currently, most studies are conducted in specialist centres rather than in general practices. If this proposal is successful, more studies can be conducted in general practices (where most patients are seen). More evidence will be available to guide patients and physicians on how to treat diseases. All information in this study will be fully anomymised (the researchers will not know the patient??s name and contact details) and will be collected from the General Practice Research Database that is widely used for monitoring of side-effects and research in diseases.This is a feasibility study on a relatively small number of participants to assess whether the "simple study methodology" of recruitment in routine clinical care and of data collection using standard NHS records could be used to run studies in general practice.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/29

• Date of REC Opinion

  3 Mar 2011

• REC opinion

  Further Information Favourable Opinion