Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000014651
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
18/07/2005
Date last updated
18/07/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute Exacerbations of COPD: Role of Short Course Steroids
Scientific title
A randomised double blind study of short course systemic steroids versus conventional 14 days course in acute exacerbations of COPD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 76 0
Condition category
Condition code
Respiratory 93 93 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prednisolone 0.5mg/Kg for 14 days
Intervention code [1] 13 0
Treatment: Drugs
Comparator / control treatment
Prednisolone of 1 mg/kg for 3days (max 50 mg)+ 11 day placebo
Control group
Placebo

Outcomes
Primary outcome [1] 120 0
Length of stay in hospital
Timepoint [1] 120 0
Secondary outcome [1] 279 0
Rate of treatment failure
Timepoint [1] 279 0
Rebound exacerbation over the one month period following cessation of short course versus conventional corticosteroid treatment.
Secondary outcome [2] 280 0
Symptom score
Timepoint [2] 280 0
Secondary outcome [3] 281 0
Lung function tests
Timepoint [3] 281 0
Secondary outcome [4] 282 0
Sputum cellularity
Timepoint [4] 282 0

Eligibility
Key inclusion criteria
All patients admitted to the Royal Hobart Hospital with the primary diagnosis of Acute exacerbation of COPD
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Julian date
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 127 0
University
Name [1] 127 0
School of Medicine, University of Tasmania
Country [1] 127 0
Australia
Funding source category [2] 128 0
Government body
Name [2] 128 0
Applied for National Health & Medical Research Council funding
Country [2] 128 0
Australia
Primary sponsor type
University
Name
UTas
Address
Country
Australia
Secondary sponsor category [1] 93 0
University
Name [1] 93 0
School of Medicine
Address [1] 93 0
Country [1] 93 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 884 0
Southern tasmanian ethics commitee
Ethics committee address [1] 884 0
Ethics committee country [1] 884 0
Australia
Date submitted for ethics approval [1] 884 0
Approval date [1] 884 0
Ethics approval number [1] 884 0
H8356

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35447 0
Address 35447 0
Country 35447 0
Phone 35447 0
Fax 35447 0
Email 35447 0
Contact person for public queries
Name 9202 0
Dr David Reid
Address 9202 0
Clinical School of Medicine
43 Collins Street
Hobart TAS 7001
Country 9202 0
Australia
Phone 9202 0
+61 3 62267043
Fax 9202 0
+61 3 62264894
Email 9202 0
[email protected]
Contact person for scientific queries
Name 130 0
Dr Himanshu Garg
Address 130 0
Clinical School of Medicine
43 Collins Street
Hobart TAS 7001
Country 130 0
Australia
Phone 130 0
+61 3 62264846
Fax 130 0
+61 3 62264894
Email 130 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.