Reducing periOperative Adverse Respiratory events (ROAR) in children undergoing adenotonsillectomy who present with recurrent respiratory symptoms

Effect of fluticasone propionate for the prevention of perioperative respiratory complications in children undergoing adenotonsillectomy who present with recurrent respiratory symptoms

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000243112

Acronym

ROAR

Enrollment

Registered

2019-02-19

Start date

2019-09-04

Completion date

2021-01-21

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Children with asthma or recurrent respiratory symptoms are at an increased risk of developing respiratory complications such as bronchospasm in the perioperative period. These risks are higher in surgeries such as adenotonsillectomy. Seven out of ten children with both respiratory symptoms and airway inflammation experienced at least one respiratory complication compared with only 1 out of 10 children with respiratory symptoms but no active airway inflammation. We hypothesize that children with recurrent respiratory symptoms screened for the presence of airway inflammation using the non-invasive measurement of exhaled nitric oxide and randomised to receiving ICS (Fluticasone propionate 250mcg per day) for 14 days prior to their adenotonsillectomy will be at a lower risk of having respiratory complications in the perioperative period compared with those receiving routine clinical care.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

4 Years to 10 Years

Healthy volunteers

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

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)

Outcome results