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Trial registered on ANZCTR


Registration number
ACTRN12616001439437
Ethics application status
Approved
Date submitted
12/10/2016
Date registered
14/10/2016
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Date results information initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of nasal sprays for treatment of allergic rhinitis and changes in local gene expression
Scientific title
Mapping allergic rhinitis networks: comparative analysis of the effects of a topical antihistamine, topical nasal steroid and combined antihistamine and steroid on immune phenotype in allergic rhinitis
Secondary ID [1] 290316 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
allergic rhinitis 300578 0
Condition category
Condition code
Inflammatory and Immune System 300431 300431 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Allocation to one of three nasal sprays. Twice daily application (one spray per nostril) for 7 days.

The nasal sprays include:
(A) an intranasal antihistamine (Azep; Azelastine hydrochloride 125 mcg/spray)
(B) an intranasal steriod (Flixonase; Fluticasone proprionate 50mcg/spray)
(C) an intranasal antihistamine and steriod combination (Dymista: Azelastine hydrochloride and Fluticasone proprionate 125/50 mcg per spray).

Compliance will be monitored with return and weighing of spray bottle and self-report in daily symptom and medication diaries
Intervention code [1] 296128 0
Treatment: Drugs
Comparator / control treatment
Comparing the effects of three sprays
Control group
Active

Outcomes
Primary outcome [1] 299870 0
Gene expression profiles in nasal mucosal cells following nasal spray administration. This will be assessed using the Nanostring ncounter platform using the PanCancer immune profiling kit (770 genes involved in immune and inflammatory pathways).
Timepoint [1] 299870 0
The intervention period is 7 days. Primary endpoints will be determined prior to administration at baseline (day 0) and at the end of treatment (day 7).
Secondary outcome [1] 328344 0
Gene expression profiles in blood following nasal spray administration.. This will be assessed using the Nanostring ncounter platform using the PanCancer immune profiling kit (770 genes involved in immune and inflammatory pathways).
Timepoint [1] 328344 0
The intervention period is 7 days. Primary endpoints will be determined prior to administration at baseline (day 0) and at the end of treatment (day 7).

Eligibility
Key inclusion criteria
For inclusion into the study participants will: have a more than 2 year history of allergic rhinitis, have moderate/severe persistent allergic rhinitis based on ARIA classification, score 5 cm or greater on a visual analogue scale of symptom severity, score 6 or greater on a total nasal symptom score survey, have a positive skin prick test and/or radio-allergosorbent test to Dermatophahoides pteronyssinus or D. farnae.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from participating if they: have non-allergic rhinitis, test negative on skin prick test to Dermatophagoides pteronyssinus or D. farnae, have consumed probiotics or prebiotics in the previous 12 weeks, have undergone treatment with systemic corticosteriods in the previous 6 months, use immune-modulating medications, have history of respiratory diseases such as asthma, COPD or other medical conditions such as glaucoma or hepatic impairment, reports excessive alcohol consumption, have history of nasal polyposis, nasal ulcers, recent nasal surgery or nasal trauma, are pregnant, have current illness with bacterial or viral infection, have known hypersensitivity to Azep, Flixonase or Dymista .

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)
Allocation concealed - sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on sensitivity to allergens (dust mite only vs dustmite and grass allergy), gender and age. Simple randomisation table - computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 294700 0
Commercial sector/Industry
Name [1] 294700 0
Meda Pharmaceuticals Pty Ltd
Address [1] 294700 0
Meda Pharma GmbH & Co. KG
Benzstrasse 1, 61352 Bad Homburg,
Country [1] 294700 0
Germany
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast Campus
University Drive
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 293545 0
Other
Name [1] 293545 0
QLD Allergy Services Clinic
Address [1] 293545 0
Pacific Private Hospital
Level 5, Suite 4
123 Nerang street
Southport, QLD, 4215
Country [1] 293545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296121 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 296121 0
Office for Research
Bray Center N54_0.15
Griffith University - Nathan Campus
Kessels Road
Nathan 4111
QLD
Ethics committee country [1] 296121 0
Australia
Date submitted for ethics approval [1] 296121 0
Approval date [1] 296121 0
11/10/2016
Ethics approval number [1] 296121 0

Summary
Brief summary
Antihistamines and intranasal steroid sprays are considered first line pharmacological treatment options for alleviating symptoms of allergic rhinitis. The aim of this research is to examine any link between corticosteroid vs antihistamine vs combined corticosteroid and antihistamine administration and local gene expression patterns which may reveal biological pathways involved in each treatment type .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69642 0
Dr Amanda Cox
Address 69642 0
Griffith University
Gold Coast Campus
G40_9.17
Parklands Drive
Southport
QLD 4222
Country 69642 0
Australia
Phone 69642 0
+61 07 5678 0898
Fax 69642 0
Email 69642 0
a.cox@griffith.edu.au
Contact person for public queries
Name 69643 0
Dr Nicholas West
Address 69643 0
Griffith University
Gold Coast Campus
G40_9.17
Parklands Drive
Southport
QLD 4222
Country 69643 0
Australia
Phone 69643 0
+61 07 5678 0899
Fax 69643 0
Email 69643 0
n.west@griffith.edu.au
Contact person for scientific queries
Name 69644 0
Dr Amanda Cox
Address 69644 0
Griffith University
Gold Coast Campus
G40_9.17
Parklands Drive
Southport
QLD 4222
Country 69644 0
Australia
Phone 69644 0
+61 07 5678 0898
Fax 69644 0
Email 69644 0
a.cox@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary