Table 5.
Summary of the way in which trials define and manage exacerbations
| WISP | O'Brien et al | COPE | COSMIC | |
|---|---|---|---|---|
| Definition of exacerbation | 'The presence of at least 2 consecutive days of increase in any two 'major' symptoms (increasing breathlessness, sputum purulence and sputum production" or increase in one 'major' and one 'minor' symptom (wheeze, cough, cold/nasal congestion, sore throat, fever)''Exacerbations were classified as: Unreported: fulfilled symptom criteria on diary cards for a COPD exacerbation but was not managed with antibiotics or oral steroids Moderate: a COPD exacerbation treated with a course of antibiotics or oral steroids Severe: a COPD exacerbation treated with a course of antibiotics or oral steroids resulting in hospital admission' |
None | 'worsening of respiratory symptoms that required treatment with a short course of oral corticosteroids or antibiotics as judged by the study physician' | 'Mild: if a patient on 2 or more consecutive days used 3 or more extra inhalations of salbutamol per 24 hours above their RRV Moderate: if a course of oral steroids were indicated based on a clinician's judgement Severe: if hospitalisation was required' |
| Definition of very severe exacerbations which would warrant treatment with medication other than the randomised treatment | None | None | Rapid recurrent exacerbations: 'twice an objective increase in respiratory symptoms within a three-month period, defined as more than 20% or 300 ml decrease in FEV1, compared with stable lung function at randomisation, or 3 times a subjective increase of respiratory symptoms in a 3-month period as experienced by the patient regardless of the criteria mentioned previously' | None |
| Protocol for dealing with exacerbations | 'GP's were advised to manage exacerbations according to usual guidance with antibiotics and/or oral steroids. Decisions about stopping study inhalers were made by the general practitioner and patient' | None | 'If patients experienced any worsening of symptoms, they were advised to contact the COPE study personnel by phone. They were then invited to attend the hospital within 12 hours for spirometry and consultation by one of the study physicians who decided to continue the trial or to prescribe 500 mcg FP twice daily unblinded' | 'Standardised course of prednisolone 30 mg/day for ten days accompanied by a 10 day course of antibiotics.' |