None listed
Conditions
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 .
Interventions
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
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
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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 .
Outcome results
None listed