Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000394842
Ethics application status
Approved
Date submitted
4/04/2012
Date registered
5/04/2012
Date last updated
28/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of prednisolone to treat viral associated wheeze in pre-school aged children.
Scientific title
A prospective, randomised, double blinded, non-inferiority trial assessing the impact of oral prednisolone on hospital length of stay in pre-school aged children presenting with viral associated wheeze.
Secondary ID [1] 280231 0
Nil
Universal Trial Number (UTN)
U1111-1129-5391
Trial acronym
PREVIEW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wheeze. 286180 0
Viral upper respiratory tract infection. 286237 0
Condition category
Condition code
Respiratory 286374 286374 0 0
Asthma
Infection 286452 286452 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral prednisolone 1mg/kg once daily for 3 days.
Intervention code [1] 284565 0
Treatment: Drugs
Comparator / control treatment
Placebo once daily for 3 days.
Solution matched to inactive base solution for the prednisolone solution (Redipred).
Control group
Placebo

Outcomes
Primary outcome [1] 286832 0
Length of stay (LOS) within the Emergency Department (ED) from time study drug administered until the patient is deemed fit for discharge.
Timepoint [1] 286832 0
From time of study drug adminstration until discharge-ready time and actual discharge time.
Primary outcome [2] 286833 0
Length of stay (LOS) within the hospital from time study drug administered until the patient is deemed fit for discharge.
Timepoint [2] 286833 0
From time of study drug administration until discharge-ready time and actual discharge time
Secondary outcome [1] 296764 0
Hospital admission rate (ED short stay ward or inpatient ward) - based on criteria for admission guidleines for wheeze.
Timepoint [1] 296764 0
During initial enrolement attendance.
Secondary outcome [2] 296765 0
Unscheduled Hospital / GP re-attendance rate as assessed by follow-up telephone call and review of parent completed 7-day patient symptom diary.
Timepoint [2] 296765 0
Within 7-days post enrolement.
Secondary outcome [3] 296766 0
Hospital re-admission rate - assessed by follow-up telephone call, review of parent completed 7-day patient symptom diary and review of hospital computer based ED attendance records.
Timepoint [3] 296766 0
Within 7-days post enrolement
Secondary outcome [4] 296767 0
Influence of virus type on disease severity - virus identified from nasal flocked swab sample.
Timepoint [4] 296767 0
Review of patient progress in relation to virus identified on enrolement attendnace.
Secondary outcome [5] 296768 0
Impact of corticosteroid therapy in wheeze associated with different virus types.
Timepoint [5] 296768 0
Review of viruses identified in patients on enrolement attendance and their subsequent clinical progress when comparing patients receiving corticosteroid versus placebo.
Secondary outcome [6] 296769 0
Influence of virus type on symptom duration and the impact of corticosteroids on symptom duration. Assessed by follow-up telephone call and review of parent completed 7-day patient symptom diary.
Timepoint [6] 296769 0
Review of viruses identified in patients on enrolement attendance and their subsequent clinical progress when comparing patients receiving corticosteroid versus placebo.
Secondary outcome [7] 296770 0
Influence of virus type on recurrance of symptoms and the impact of corticosteroids on prevention of recurrance. Assessed by follow-up telephone call.
Timepoint [7] 296770 0
Follow up telephone call 3 months from enrolement attendance.
Secondary outcome [8] 296771 0
Analysis of patient demographics to assess for characteristics that provide a clinical index for corticosteroid responsiveness including baseline clinical observations at enrolement presentation.
Timepoint [8] 296771 0
Following 3 month follow up telephone call reviewed in conjunction with data from enrolement presentation and patient questionnaire.
Secondary outcome [9] 296772 0
Mean number of salbutamol treatments given during hospital attendance assessed through review of medical records.
Timepoint [9] 296772 0
During enrolement attendance.
Secondary outcome [10] 296773 0
Mean number of salbutamol treatments given during the 7-day period after discahrge from hospital. Assessed Assessed by follow-up telephone call and review of parent completed 7-day patient symptom diary.
Timepoint [10] 296773 0
Review of 7-day period after discharge from hospital.
Secondary outcome [11] 296774 0
Mean duration of residual symptoms in the 7-day period after discharge from hospital. Assessed by follow-up telephone call and review of parent completed 7-day patient symptom diary.
Timepoint [11] 296774 0
Review of 7-day period after discharge from hospital.
Secondary outcome [12] 296775 0
The incidence of additional therapies for treatment of wheeze introduced in the 7-day period after discharge from hospital. Assessed by follow-up telephone call and review of parent completed 7-day patient symptom diary.
Timepoint [12] 296775 0
Review of 7-day period after discharge from hospital.
Secondary outcome [13] 296776 0
The incidence of recurrence of wheeze, medications regularly administered for wheeze and the number of medical attendances for wheeze in each study arm at 3 months after enrolement attendance. Assessed by follow-up telephone call.
Timepoint [13] 296776 0
Follow up telephone call 3 months from enrolement attendance.
Secondary outcome [14] 296777 0
Incidence of vomiting and other significant adverse events within the 7-day period from enrolement. Assessed by review of medical records, follow-up telephone call and review of parent completed 7-day patient symptom diary.
Timepoint [14] 296777 0
Review of 7-day period from enrolement attendance.

Eligibility
Key inclusion criteria
1. Clinical diagnosis of wheeze.
2. Presence of symptoms or signs of an intercurrent or recent (within 72hrs) viral upper respiratory tract infection.
Minimum age
24 Months
Maximum age
72 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presenting oxygen saturation (SpO2) less than 92% in room air.
2. Features of "critical wheeze" - (silent chest on auscultation and/or exhaustion with or without cyanosis)
3. Clinical evidence of shock or bacterial sepsis.
4. Active varicella infection.
5. High clinical suspicion of alternative diagnosis for wheeze (for example - inhaled foreign body).
6. Previous PICU admission with wheeze / asthma.
7. Premature birth - defined as <34 weeks gestation.
8. Known cardiac / other respiratory disease.
9. Recieving immunosuppresant therapy or known to have immunodeficiency.
10. Upper respiratory tract structural abnormality.
11. Oral corticosteroid therapy within the last 14 days.
12. Previously recruited to this study.
13. Known allergy to Prednisolone.

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)
All children, between the ages of 24 to 72 months of age, presenting to the ED with acute wheeze will be considered for the study. Wheeze will be defined by clinical criteria provided by the assessment of the first attending ED physician. The ED physician will then clinically judge if the presenting wheezing episode was preceded by or associated with the symptoms of a viral upper respiratory tract infection. If the patient satisfies these criteria and the full study inclusion / exclusion criteria they will be approached for inclusion to the study with written consent obtained for all children enrolled.
The patient will then receive the next sequentially numbered study drug from the dispensory. Solutions labelled with study numbers will be given out in numerical order to maintain randomisation with block randomization.
The study drugs will be formulated by the clinical trials pharmacy and will be matched for volume, concentration, colour, smell and taste. Each study bottle will have no identifying markings indicating difference between placebo and prednisolone. The solutions will be prepared and packed in individual bottles identified by a 4-digit study number on the label.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation process administered by clinical trials pharmacist who maintains the randomisation schedule and will label all bottles with blinded study numbers. The randomisation code will be retained in a locked cupboard in the pharmacy department until the end of the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Non-inferiority trial - prednisolone versus placebo.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2012
Actual
11/06/2012
Date of last participant enrolment
Anticipated
Actual
11/06/2015
Date of last data collection
Anticipated
Actual
11/09/2015
Sample size
Target
700
Accrual to date
Final
608
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285043 0
Government body
Name [1] 285043 0
State Health Research Advisory Council (SHRAC) - Targeted Research Fund (TRF)
Country [1] 285043 0
Australia
Primary sponsor type
Individual
Name
Dr Steven Foster - ED Fellow
Address
Emergency Department,
Princess Margaret Hospital for Children
Roberts Road
Subiaco 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 283908 0
Individual
Name [1] 283908 0
Professor Gary Geelhoed
Address [1] 283908 0
Emergency Department,
Princess Margaret Hospital for Children
Roberts Road
Subiaco 6008
Western Australia
Country [1] 283908 0
Australia
Secondary sponsor category [2] 283909 0
Individual
Name [2] 283909 0
Dr Meredith Borland
Address [2] 283909 0
Emergency Department,
Princess Margaret Hospital for Children
Roberts Road
Subiaco 6008
Western Australia
Country [2] 283909 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287049 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 287049 0
Ethics committee country [1] 287049 0
Australia
Date submitted for ethics approval [1] 287049 0
15/03/2012
Approval date [1] 287049 0
22/03/2012
Ethics approval number [1] 287049 0
1970/EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33989 0
A/Prof Meredith Borland
Address 33989 0
Emergency department, Princess Margaret Hospital for Children, Roberts Road, Subiaco 6008, Western Australia
Country 33989 0
Australia
Phone 33989 0
+61 8 93408380
Fax 33989 0
Email 33989 0
[email protected]
Contact person for public queries
Name 17236 0
A/Prof Meredith Borland
Address 17236 0
Emergency Department,
Princess Margaret Hospital for Children
Roberts Road
Subiaco 6008
Western Australia
Country 17236 0
Australia
Phone 17236 0
+61 8 9340 8380
Fax 17236 0
Email 17236 0
[email protected]
Contact person for scientific queries
Name 8164 0
Dr Steven Foster
Address 8164 0
Emergency Department,
Princess Margaret Hospital for Children
Roberts Road
Subiaco 6008
Western Australia
Country 8164 0
Australia
Phone 8164 0
+61 8 9340 8380
Fax 8164 0
Email 8164 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
SourceTitleYear of PublicationDOI
EmbaseOral prednisolone in preschool children with virus-associated wheeze: a prospective, randomised, double-blind, placebo-controlled trial.2018https://dx.doi.org/10.1016/S2213-2600%2818%2930008-0
N.B. These documents automatically identified may not have been verified by the study sponsor.