None listed
Conditions
Brief summary
Allergic rhinitis (AR), or hayfever, is an allergic condition which is associated with inflammation of the lining of the nasal passages. It is associated with significant morbidity for a substantial proportion of children. International guidelines recommend intranasal corticosteroids (INCS) as first line treatment for persistent or moderate to severe intermittent allergic rhinitis. From a child’s point of view, nasal steroids may be associated with an unpleasant sensation without an obvious benefit. This study will compare fluticasone and budesonide inhaled corticosteroid in terms of taste, sensation, delivery and adherence in children aged 6-14 years. Patients will be recruited from outpatient clinics at the Mater Children’s Hospital. All participants will be required to provide informed written consent. There are two parts to this study. The first part will see the sensory attributes and device preference. A random number generator will be used to randomly allocate the order in which Budesonide or Fluticasone are taken. The subject will spray Medication 1 into their nose as per the instructions provided and then complete Questionnaire for Medication 1. The subject will be instructed to have a sip of water, eat a biscuit, smell a swatch of wool and wait 20 minutes before taking Medication 2 and then completing Questionnaire for medication 2. The second part of the study will see short term adherence. If the subject is willing to participate in Part 2 they will be asked to use Medication 1, for 4 weeks as part of the treatment for their allergic rhinitis. At the end of 4 weeks they will be asked to complete Questionnaire after 4 weeks of Medication 1 and send it and the Medication 1 bottle back to the investigators. The bottle will be weighed to estimate the amount of medication used. The primary outcome measure of the study is overall preference of Medication 1 or 2.
Interventions
The subject will take Budesonide or Fluticasone intranasal spray, one spray each per nostril in a randomly allocated order in phase 1 of the study. They will be labelled as medication A and medication B. Budesonide spray to be used will be 32 micrograms per spray per nostril. Fluticasone spray to be used will be 27.5 micrograms per spray per nostril.
For phase 2, Medication A which will be one of the randomly allocated medications from phase 1, Budesonide or Fluticasone, will be used one spray p
The subject will take Budesonide or Fluticasone intranasal spray, one spray each per nostril in a randomly allocated order in phase 1 of the study. They will be labelled as medication A and medication B. Budesonide spray to be used will be 32 micrograms per spray per nostril. Fluticasone spray to be used will be 27.5 micrograms per spray per nostril. For phase 2, Medication A which will be one of the randomly allocated medications from phase 1, Budesonide or Fluticasone, will be used one spray per nostril daily for 4 weeks. Wash- out periods between treatments will be in phase one. After taking Medication A, the participant will be instructed to have a sip of water, eat a biscuit, smell a swatch of wool and wait 20 minutes before taking Medication B, one of the randomly allocated medications, Budesonide or Fluticasone. The aim is to allow the senses to recover and start afresh for the second medication.
Sponsors
Mater Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1.Children aged 6-14 years. 2.Symptoms of perennial allergic rhinitis which following clinician assessment is felt to warrant treatment (persistent or moderate to severe intermittent allergic rhinitis). 3. Not currently using a nasal corticosteroid.
Exclusion criteria
1. Hypersensitivity or intolerance to steroids. 2. Currently using or having used an inhaled corticosteroid in the previous month. 3. Currently taking Montelukast. 4. No sense of smell. 5. Receiving immunotherapy. 6. Epistaxis in the previous week. 7. Evidence of broken skin involving the nasal mucosa.
Outcome results
None listed