None listed
Conditions
Brief summary
Glue ear is a common childhood condition where fluid behind the eardrum can cause hearing difficulty and affect speech, learning and wellbeing. Nasal steroid medicines are sometimes used when children also have nasal blockage or allergy symptoms, but many children find standard liquid nasal sprays unpleasant or difficult to use. This study compares two ways of delivering the same nasal steroid medicine, fluticasone. Children will use a standard aqueous nasal spray for four weeks and a metered-dose inhaler with a nasal adaptor for four weeks, in alternating order. The study will ask children and caregivers which method they prefer, how comfortable each is to use, and how regularly it is used. The study is not designed to determine which treatment improves glue ear more effectively. Instead, it will help establish whether the inhaler-and-adaptor method is acceptable and feasible for children before a larger study of clinical effectiveness is undertaken.
Interventions
This trial is set up as a randomised cross over trial. Each participant will use both study devices (Fluticasone delivered via the nasal adaptor and the fluticasone aqueous spray). Each device will be used once daily for 4 weeks, giving a total intervention period of 8 weeks with no planned washout period.
Participants will be allocated to device order using an randomised allocation (A->B or B->A) to minimise systematic order effects: approximately half will receive standard aqueous intranasal
This trial is set up as a randomised cross over trial. Each participant will use both study devices (Fluticasone delivered via the nasal adaptor and the fluticasone aqueous spray). Each device will be used once daily for 4 weeks, giving a total intervention period of 8 weeks with no planned washout period. Participants will be allocated to device order using an randomised allocation (A->B or B->A) to minimise systematic order effects: approximately half will receive standard aqueous intranasal fluticasone first followed by MDI plus nasal adaptor, and approximately half will receive MDI plus nasal adaptor first followed by standard aqueous intranasal fluticasone. The intended allocation is therefore approximately 1:1 by treatment sequence: Adherence will be monitored using a drug diary as well as a child/caregiver-reported compliance through the paediatric-adapted Clinical Trial Patient Preference Questionnaire after each treatment period, reminder phone calls during the study, and return of both devices at the end of the study to be weighed to estimate the number of doses left at the end of the study. Intervention - Fluticasone via MDI + 3D printed nasal adaptor ================================================================ Fluticasone delivered intranasally via a pressurised metered-dose inhaler fitted with a custom 3D-printed nasal adaptor. The adaptor is made from Tough 1500 Resin and enables intranasal administration of the same fluticasone medication used in the comparator arm. Participants use the device once daily for 4 weeks following standardised caregiver instruction. Fluticasone 125 micrograms per actuation through MDI, 1 actuation per nostril once daily. (From biomedical model 30% of dose adheres to the 3D printed nasal adaptor so dose equivalence to comparator)
Sponsors
University of Auckland - Department of Surgery - Faculty of Medical and Health Sciences
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Children aged 4–12 years with otitis media with effusion managed within standard secondary-care OME pathways, with: • Type B or C tympanogram and/or documented conductive hearing loss on audiometry and/or clinical diagnosis of OME • atopic-type nasal symptoms, defined as nasal obstruction and/or runny nose; and/or hay fever • parent/legal guardian able to provide written informed consent; and • child assent where developmentally appropriate.
Exclusion criteria
Craniofacial anomalies affecting nasal or Eustachian-tube anatomy; primary ciliary dyskinesia or cystic fibrosis; hypersensitivity to intranasal corticosteroids; acute upper respiratory tract infection at enrolment; diabetes treated with insulin or prescribed medication; kidney disease including renal tumour or transplant; chronic lung disease or recurrent lung infections; severe hepatic disease or liver transplant/pending transplant; adenoidectomy or grommet insertion in the previous 3 months; or solid-organ transplant.
Outcome results
None listed