None listed
Conditions
Brief summary
Chronic rhinosinusitis (CRS) is a condition characterised by inflammation of the sinonasal mucosa which lasts for more than three months. Symptoms include nasal discharge, sneezing and nasal congestion. CRS is common in the general population, having a prevalence of 5-10%. A key treatment for this condition is intranasal topical corticosteroid sprays such as fluticasone, which act to reduce sinonasal inflammation. However, at this point in time nasal drug delivery in patients with CRS is suboptimal. Patients continue to use these sprays daily even after they have had surgery. Currently, the handful of studies that describe the therapeutic efficacy of these medications have shown inconsistent results. One possible explanation for this is the limitation of the drug distribution within the sinonasal cavity. Prior research has been conducted from our group in collaboration with Auckland Bioengineering Institute to design a novel nasal adaptor that fits onto a standard metered dose (MDI) asthma inhaler, which aims to improve the dispersion of medication into the nasal cavity. Additionally, unlike the standard nasal sprays, the MDI does not require patients to lean forward during administration, nor is there an associated taste or post-nasal drip of spray. It is possible that these factors will improve patient compliance, leading to greater therapeutic efficacy. The aim of this study is to conduct a crossover trial of the novel device with a standard nasal spray in post-surgery CRS patients.
Interventions
Crossover trial comparing dispersion of fluticasone between novel nasal adaptor and a standard nasal spray.
Methods:
An experienced ENT surgeon will perform the endoscopic procedures for the placement and removal of filter paper from the sinuses at an ENT clinic. The total duration of the testing session will take approximately 45 minutes.
To measure the dispersion achieved by the novel nasal adaptor, filter paper circles of diameter 5 mm will be placed into the sinonasal cavities of 15 recov
Crossover trial comparing dispersion of fluticasone between novel nasal adaptor and a standard nasal spray. Methods: An experienced ENT surgeon will perform the endoscopic procedures for the placement and removal of filter paper from the sinuses at an ENT clinic. The total duration of the testing session will take approximately 45 minutes. To measure the dispersion achieved by the novel nasal adaptor, filter paper circles of diameter 5 mm will be placed into the sinonasal cavities of 15 recovered post-surgery chronic rhinosinusitis patients under endoscopic guidance (frontal recess, posterior wall of maxillary sinus and front face of sphenoid inferior to the sphenoidotomy). Fluticasone (125 ug) will be administered through a metered dose inhaler with the novel adapter attached. The angle of the administration into the anterior nares will be delivered and carefully controlled by the investigators. This procedure will take approximately 15 minutes. After administration, the filter paper circles will be retrieved. Patients will then be asked to perform a saline lavage and new filter dots will be placed in the same sinonasal locations. This part will take approximately 15 minutes. The same procedure will be repeated with a standard spray (more details are provided in the control treatment field). This part of the testing will take approximately 15 minutes.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients meeting the criteria of the 2020 European Position Paper (EPOS) definition of CRS patients with and without polyposis. CRS patients that have undergone FESS
Exclusion criteria
- Current malignant or significant cardiovascular disease - Current smokers, i.e. those who had smoked within the last 12 months. - Diabetes treated with insulin or other prescribed medications - History of kidney disease as an adult, including renal tumour or transplant - History of chronic lung diseases - History of recurrent lung infections - History of severe hepatic disease/liver transplant/pending liver transplant. - History of severe or multiple allergies, including hay-fever and perennial rhinitis - Hypertension (high blood pressure) requiring medication - Multiple myeloma - Participants with documented or suspected, clinically significant alcohol or drug abuse - Pregnant - Significant upper and/or lower respiratory tract infection within the previous 4 weeks - Solid organ transplant
Outcome results
None listed