Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000562976
Ethics application status
Approved
Date submitted
11/05/2011
Date registered
1/06/2011
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Date results information initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Corticosteroids in Asthma
Scientific title
Randomised, placebo controlled trial investigating adverse effects of Oral Corticosteroids in adults with stable asthma
Secondary ID [1] 262140 0
Nil
Universal Trial Number (UTN)
U1111-1121-2419
Trial acronym
CIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 265818 0
Condition category
Condition code
Respiratory 265972 265972 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adults with stable asthma will be randomised to receive a 10 day course of either 1 x Prednisolone 25mg oral capsule twice daily or 1 x placebo oral capsule twice daily and after a 6 week wash out period subjects will begin a 10 day course of the alternate treatment.
Intervention code [1] 264554 0
Treatment: Drugs
Comparator / control treatment
As this is a cross-over design, all subjects will receive in random order the active drug and the placebo, which is identical in taste and appearance to the prednisolone without containing the active drug, in the form of an oral microcellulose capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 266716 0
Serum Leptin levels
Timepoint [1] 266716 0
Visit 1 on day 1, visit 2 on day 10, visit 3 on day 52 and visit 4 on day 62.
Primary outcome [2] 266717 0
Subject body weight (kg) to nearest 100g using NU Weigh Log842 scales and weighing in light clothing
Timepoint [2] 266717 0
Visit 1 on day 1, visit 2 on day 10, visit 3 on day 52 and visit 4 on day 62.
Primary outcome [3] 266718 0
Serum Osteocalcin levels
Timepoint [3] 266718 0
Visit 1 on day 1, visit 2 on day 10, visit 3 on day 52 and visit 4 on day 62.
Secondary outcome [1] 276244 0
Body composition - changes in fat, lean muscle and fluid compartments using whole body scans from dual energy x-ray absoptiometry (DEXA) GE Lunar machine.
Timepoint [1] 276244 0
visit 2 on day 10 - visit 1 on day 1, visit 4 on day 62 -visit 3 on day 52, visit 4 on day 62 - visit 1 on day 1. (all subjects have the same visits at the same time points regardless of whether they are on the active or alternate treatment, with treatment starting at day 1/visit 1 and ending at day 62/visit 4)
Secondary outcome [2] 276271 0
Dietary Intake in kJ measured by 4 day food records and 24hr recalls. Records will be analysed by Foodworks nutritional analysis software (Xyris). A change in intake of 2000 kJ will be considered significant.
Timepoint [2] 276271 0
Visit 1 on day 1, visit 2 on day 10, visit 3 on day 52 and visit 4 on day 62.

Eligibility
Key inclusion criteria
Adults with stable asthma not currently taking oral corticosteroid medication or other medications known to interact with them. No asthma exacerbation, respiratory tract infection or oral corticosteroids in the previous 4 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years old, diabetes mellitus.

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)
After a screening visit eligible participants will be randomised by hospital pharmacy to receive either the treatment drug or placebo first. Treatment group allocation will not be revealed to the study investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pharmacy will generate randomisation code using computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
30/04/2013
Date of last data collection
Anticipated
Actual
3/07/2013
Sample size
Target
65
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4008 0
2305

Funding & Sponsors
Funding source category [1] 265046 0
University
Name [1] 265046 0
University of Newcastle
Country [1] 265046 0
Australia
Primary sponsor type
Individual
Name
A/Prof Lisa Wood
Address
Center for Asthma & Respiratory Diseases
Hunter Medical Research Institute
Level 2, West Wing, Lot 1 Kookaburra Circuit
New Lambton Heights, 2305, NSW, Australia
Country
Australia
Secondary sponsor category [1] 264146 0
University
Name [1] 264146 0
University of Newcastle
Address [1] 264146 0
University Drive, Callaghan, 2308, NSW
Country [1] 264146 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267036 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 267036 0
Ethics committee country [1] 267036 0
Australia
Date submitted for ethics approval [1] 267036 0
13/05/2011
Approval date [1] 267036 0
25/07/2011
Ethics approval number [1] 267036 0
11/06/15/3.03

Summary
Brief summary
There is some evidence to suggest that oral corticosteroid medications may increase appetite and lead to weight gain. However it is unknown whether people with asthma experience these effects when prescribed oral corticosteroids when their asthma symptoms worsen. This study is designed to examine whether taking oral corticosteroids for a short time affects appetite, dietary intake, body weight or body composition and bone metabolism.
Trial website
N/A
Trial related presentations / publications
Berthon BS, Gibson PG, McElduff P, et al. Effects of short term oral corticosteroid intake on dietary intake, body weight and body composition in adults with asthma- a randomised controlled trial. Clin Exp Allergy 2015 (epub before print).
Public notes

Contacts
Principal investigator
Name 32591 0
Prof Lisa Wood
Address 32591 0
The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 32591 0
Australia
Phone 32591 0
+61240420147
Fax 32591 0
Email 32591 0
[email protected]
Contact person for public queries
Name 15838 0
Dr Bronwyn Berthon
Address 15838 0
The University of Newcastle (UON)
Hunter Medical Research Institute
Level 2, West Wing
C/- University Drive
Callaghan NSW 2308
Australia
Country 15838 0
Australia
Phone 15838 0
+61 2 40420116
Fax 15838 0
+61 2 40420046
Email 15838 0
[email protected]
Contact person for scientific queries
Name 6766 0
Prof Lisa Wood
Address 6766 0
Center for Asthma & Respiratory Diseases
Hunter Medical Research Institute
Level 2, West Wing, Lot 1 Kookaburra Circuit
New Lambton Heights, 2305, NSW, Australia
Country 6766 0
Australia
Phone 6766 0
+61 2 4042 0147
Fax 6766 0
+61 2 4042 0046
Email 6766 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan for IPD sharing for this trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA sputum gene expression signature predicts oral corticosteroid response in asthma.2017https://dx.doi.org/10.1183/13993003.00180-2017
EmbaseEffects of short-term oral corticosteroid intake on dietary intake, body weight and body composition in adults with asthma - a randomized controlled trial.2015https://dx.doi.org/10.1111/cea.12505
N.B. These documents automatically identified may not have been verified by the study sponsor.