ANZCTR - Registration

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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)

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Prednisolone 0.5mg/Kg for 14 days

Intervention code [1]

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]

Length of stay in hospital

Timepoint [1]

Secondary outcome [1]

Rate of treatment failure

Timepoint [1]

Rebound exacerbation over the one month period following cessation of short course versus conventional corticosteroid treatment.

Secondary outcome [2]

Symptom score

Timepoint [2]

Secondary outcome [3]

Lung function tests

Timepoint [3]

Secondary outcome [4]

Sputum cellularity

Timepoint [4]

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?

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]

University

Name [1]

School of Medicine, University of Tasmania

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Applied for National Health & Medical Research Council funding

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

UTas

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

School of Medicine

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern tasmanian ethics commitee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr David Reid

Address

Clinical School of Medicine
43 Collins Street
Hobart TAS 7001

Country

Australia

Phone

+61 3 62267043

Fax

+61 3 62264894

D.E.C.Reid@utas.edu.au

Contact person for scientific queries

Name

Dr Himanshu Garg

Address

Clinical School of Medicine
43 Collins Street
Hobart TAS 7001

Country

Australia

Phone

+61 3 62264846

Fax

+61 3 62264894

hgarg@utas.edu.au

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.

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