None listed
Conditions
Brief summary
The OVERALL AIM of this project is to build on our recent demonstration that the reduction in airway inflammation following introduction of systemic corticosteroids (CS) during acute exacerbations of COPD (AECOPD) is rapid and significant at 48 hours. We will now compare two CS treatment regimens: short course (72 hours only) of high dose versus more conventional, moderate dose therapy over 14 days in terms of efficacy and adverse events (AE). At the same time, we will continue our work to delineate the aetiological factors and inflammatory processes underlying AECOPD. This project will test the following hypotheses: 1 Systemic CS are effective during AECOPD because of a rapid reduction in neutrophil chemotactic cytokines and down-regulation of neutrophil-related vascular adhesion molecules; this occurs over the first 2-3 days of therapy. 2. Thus, short-course, high-dose CS therapy is as efficacious in the treatment of AECOPD as a more conventional 14-day course of moderate dose CS, but with significantly less risk of AE and without rebound of inflammation after cessation. Hospital length of stay can be reduced. 3.Exacerbations over the subsequent one month (treatment failure) are no more frequent with short versus conventional course CS therapy. 4. Viral and bacterial organisms isolated from sputum during an AECOPD are associated with a greater inflammatory response within the airway than non-infective exacerbations, but both are responsive to CS therapy. Specific aims are: 1.To build on our preliminary findings of a rapid reduction in sputum neutrophilia and improvement in symptoms by systemic CS during AECOPD and to examine whether this relates to inhibition of neutrophil-related chemotactic factors and vascular adhesion molecules. 2.To compare short-course (3 day), high dose CS treatment and more conventional 14-day moderate dose CS therapy with focus on clinical outcomes, reductions in airway inflammation, rebound exacerbation and adverse events. 3.To identify bacterial and viral organisms as well as determine bacterial load at admission and to then relate these to airway inflammation, response to treatment and rate of rebound.
Interventions
Prednisolone 0.5mg/Kg for 14 days
Sponsors
UTas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
All patients admitted to the Royal Hobart Hospital with the primary diagnosis of Acute exacerbation of COPD
Exclusion criteria
1 Patients who have already received more than one oral CS dose from their GP prior to presentation, or who have received a treatment CS course within the past one-month will not be eligible. 2 Patients on long-term oral CS at a dose of greater than 5 mg/day. 3 Significant co-morbidities such as on-going angina or current cardiac failure 4 Pneumonic consolidation, lung cancer, fibrosis, bronchiectasis or asthma.5 Inability to comply with instructions.6 Patients with inadequate social supports - these patients often have prolonged admissions once the acute phase has resolved ICS begun before admission will not be an exclusion criterion, but will be taken into account in a subgroup analysisexacerbation of COPD
Outcome results
None listed