Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000243112
Ethics application status
Approved
Date submitted
13/02/2019
Date registered
19/02/2019
Date last updated
29/06/2021
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing periOperative Adverse Respiratory events (ROAR) in children undergoing adenotonsillectomy who present with recurrent respiratory symptoms
Scientific title
Effect of fluticasone propionate for the prevention of perioperative respiratory complications in children undergoing adenotonsillectomy who present with recurrent respiratory symptoms
Secondary ID [1] 297392 0
nil
Universal Trial Number (UTN)
Trial acronym
ROAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative adverse respiratory events 311547 0
Condition category
Condition code
Anaesthesiology 310186 310186 0 0
Other anaesthesiology
Respiratory 310187 310187 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
250mcg Fluticasone propionate (Flixotide Inhaler) or placebo metered dose inhaler (MDI) for a 2 week period prior to ENT surgery. 250mcg administered as 125mcg twice daily. Adherence is monitored through diary cards detailing doses taken and reasons for any missed doses, the number of actuations remaining on returned stock and phone calls during the 14 days prior to surgery to parents to track doses and maximise compliance.
Intervention code [1] 313649 0
Prevention
Intervention code [2] 313666 0
Treatment: Drugs
Comparator / control treatment
Propellant (hydrofluoroalkane) only metered dose inhaler (MDI) for a 2 week period prior to ENT surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 319072 0
To assess the effect of treatment (Fluticasone propionate 250mcg per day) on the number of respiratory complications in the perioperative period.
Respiratory complications may include:
• Laryngospasm
• Bronchospasm
• Oxygen desaturation:
• Severe persistent coughing
• Stridor
Perioperative respiratory adverse events (PRAE) outcomes will be recorded during surgery and the recovery period in the post-anesthesia care unit (PACU)
Timepoint [1] 319072 0
Primary outcome assessed by PRAE outcomes during surgery and during the recovery period in PACU.
Secondary outcome [1] 366907 0
To assess the effect of treatment on the number of complications in the extended post-operative period. Complications may include:
• Wheeze
• Stridor
• Severe persistent coughing
• Pain
• Bleeding
This will be assessed by phone-calls during the 14 day follow-up period.
Timepoint [1] 366907 0
The extended post-operative period involves a 14 day follow-up post-surgery.
Secondary outcome [2] 366977 0
To determine the healthcare costs associated with any difference in post-surgery outcomes between the treatment groups.. To perform a health economics analysis, the following composite outcomes will be recorded:
• Length of time spent in theatre and recovery
• Unplanned admissions or prolonged hospital stays
• Additional treatments or pain relief required pre and post discharge
• Parental time off work and/or childrens time off school/day-care post discharge
• Readmission post discharge
• Additional visit to GP related to surgery post discharge
This will be assessed by a review of the participants medical notes and phone calls during the 14 day follow-up period.
Timepoint [2] 366977 0
Health economics analysis will involve a review of the above variables during the 14 day period post-surgery.

Eligibility
Key inclusion criteria
• 4 > Age < 10
• Male/Female
• Adenotonsilectomy +/- adenoidectomy, grommets, cautery of inferior turbinates, or examination of the ear under general anaesthesia with the use of laryngeal mask airway or endotracheal tubes
• Respiratory symptoms in the past 12 months including:
- wheeze
- shortness of breath
- 4 weeks cough
- exercise induced respiratory symptoms
• eNO measurement greater than or equal to 20 ppb
Minimum age
4 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• 4 > Age > 10
• Cystic Fibrosis, bronchiectasis
• Significant cardiac disease
• Preventer asthma medications other than the study intervention in the last 3 months such as:
- Inhaled corticosteroids (other than the supplied study intervention e.g. budenoside, beclomethasone dipropionate, mometasone furoate, ciclesonide)
- Long-acting beta agonists (other than study intervention) or an extended release short-acting beta-agonist
- Leukotriene-receptor agonists (e.g. montelukast), theophylline, cromolyn, or other non-inhaled/oral corticosteroid asthma controller medications
• Prescription or over the counter medications that would significantly interact with beta-agonists or inhaled corticosteroids
• Potent Cytochrome P450 3A4 (CYP3A4) inhibitors within 4 weeks of Visit 1 and during the double-blind treatment period (e.g. clarithromycin, ritonavir, ketoconazole, itraconazole)
• Inhaled anti-cholinergics (e.g. tiotropium, ipratropium)
• Anti-IgE (e.g. Xolair [omalizumab])
• Other immunomodulators (e.g. azathioprine, cyclosporine, methotrexate)
• Anticonvulsants (barbiturates, hydantoins and carbamazepine)
• Polycyclic antidepressants
• beta-adrenergic blocking agents
• Phenothiazines
• Monoamine oxidase (MAO inhibitors)

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

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2019
Actual
4/09/2019
Date of last participant enrolment
Anticipated
Actual
21/01/2021
Date of last data collection
Anticipated
Actual
21/01/2021
Sample size
Target
80
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301964 0
Government body
Name [1] 301964 0
Department of Health - Telethon-Perth Children’s Hospital Research Fund 2017
Country [1] 301964 0
Australia
Funding source category [2] 301967 0
Government body
Name [2] 301967 0
Department of Health - Research Translation Projects 2018
Country [2] 301967 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, Western Australia, 6009
Country
Australia
Secondary sponsor category [1] 301737 0
None
Name [1] 301737 0
Address [1] 301737 0
Country [1] 301737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302644 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 302644 0
Ethics committee country [1] 302644 0
Australia
Date submitted for ethics approval [1] 302644 0
16/10/2018
Approval date [1] 302644 0
13/02/2019
Ethics approval number [1] 302644 0
RGS0000001384

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

Contacts
Principal investigator
Name 90914 0
Prof Graham Hall
Address 90914 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 90914 0
Australia
Phone 90914 0
+61 8 6319 1594
Fax 90914 0
Email 90914 0
[email protected]
Contact person for public queries
Name 90915 0
Elizabeth Smith
Address 90915 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 90915 0
Australia
Phone 90915 0
+61 8 6319 1178
Fax 90915 0
Email 90915 0
[email protected]
Contact person for scientific queries
Name 90916 0
Britta Regli-Von Ungern
Address 90916 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands, Western Australia, 6009
Country 90916 0
Australia
Phone 90916 0
+61 8 6456 4805
Fax 90916 0
Email 90916 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


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.