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Trial registered on ANZCTR


Registration number
ACTRN12613001148763
Ethics application status
Not yet submitted
Date submitted
9/10/2013
Date registered
15/10/2013
Date last updated
15/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Fluticasone and Budesonide Intranasal Corticosteroid in Terms of Taste, Sensation, Delivery and Adherence in Children Aged 6-14 Years with Allergic Rhinitis (Hayfever)
Scientific title
Comparison of Fluticasone and Budesonide Intranasal Corticosteroid in Terms of Taste, Sensation, Delivery and Adherence in Children Aged 6-14 Years with allergic rhinitis (Hayfever)
Secondary ID [1] 283197 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SNOT (Sensory outcome nasal trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis 290122 0
Condition category
Condition code
Inflammatory and Immune System 290506 290506 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 287923 0
Treatment: Drugs
Comparator / control treatment
There are two phases. In phase one it is a cross-over trial with subjects taking both medications, Budesonide or Fluticasone, in random order. The same participants will be involved in phase 2. Phase two is a randomised controlled trial comparing two medications, Budesonide and Fluticasone. In phase 2 the participant if willing will be asked to use Medication A, which will be randomly allocated Budesonide or Fluticasone as part of the treatment for their allergic rhinitis for 4 weeks. Medication B, again randomly allocated Budesonide or Fluticasone will be the comparator. If randomly allocated medication A is Budesonide then medication B will be Fluticasone and vice versa. All participants in phase 2 will take medication A, randomly allocated Budesonide or Fluticasone.
Control group
Active

Outcomes
Primary outcome [1] 290461 0
Patient preference for one of the two medications will be the primary outcome.

The Hedonic scale of facial expressions will be used in the questionnires to effectively evaluate the taste of medicines in the participants. They will be presented with pictures of 5 faces ranging from smiling to frowning.

Timepoint [1] 290461 0
Immediately after one dose of each medication.
Secondary outcome [1] 304559 0
The secondary outcome will be adherence with medication as determined by weight and thus assumed amount of medication used.


Timepoint [1] 304559 0
One month.

Eligibility
Key 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.
Minimum age
6 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited from outpatient clinics (ENT, Respiratory clinics) at the Mater Children’s Hospital. There will be posters about the study in these clinics. All participants will be required to provide informed written consent.

The subject and / or their parents (depending upon their age) will be asked to complete a basic demographic and clinical questionnaire . This includes a validated allergic rhinitis symptom severity score.

For phase 1, the subject will take two medications in order, completing a questionnaire after each medication.

A random number generator will be used to randomly allocate the order in which Budesonide or Fluticasone are taken. This allocation will be linked with a study number. The child and investigator will not be aware of the order until after informed consent is provided. After enrolment the investigator will open an opaque envelope to reveal the order in which the medications are to be given.

In phase 2, the subject will take Medication A, which will be the randomly allocated Budesonide or Fluticasone from phase 1, for 4 weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used by a research assistant in random blocks which will be used for both phase 1 and 2 of the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome measure of the study is overall preference of Medication 1 or 2. To detect a difference of 30% between the two medications, at a 5% significance value and 80% power, it has been calculated that a minimum of 98 subjects would be required. A total of 110 subjects will be recruited to allow for attrition.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1531 0
Mater Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 7370 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 287943 0
Self funded/Unfunded
Name [1] 287943 0
Dr Scott Burgess
Address [1] 287943 0
Mater Childrens Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country [1] 287943 0
Australia
Primary sponsor type
Other
Name
Mater Health Services
Address
Raymond Terrace
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 286826 0
None
Name [1] 286826 0
Address [1] 286826 0
Country [1] 286826 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289871 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 289871 0
Mater Health Services
Raymond Terrace
South Brisbane
QLD 4101
Ethics committee country [1] 289871 0
Australia
Date submitted for ethics approval [1] 289871 0
30/09/2013
Approval date [1] 289871 0
Ethics approval number [1] 289871 0

Summary
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.




Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42858 0
Dr Scott Burgess
Address 42858 0
Mater Childrens Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 42858 0
Australia
Phone 42858 0
61 7 3163 8382
Fax 42858 0
Email 42858 0
scott.burgess@mater.org.au
Contact person for public queries
Name 42859 0
Dr Vinita Prasad
Address 42859 0
Mater Childrens Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 42859 0
Australia
Phone 42859 0
61 7 3163 8111
Fax 42859 0
Email 42859 0
vinita.prasad@mater.org.au
Contact person for scientific queries
Name 42860 0
Dr Scott Burgess
Address 42860 0
Mater Childrens Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 42860 0
Australia
Phone 42860 0
61 7 3163 8382
Fax 42860 0
Email 42860 0
scott.burgess@mater.org.au

No data has been provided for results reporting
Summary results
Not applicable