None listed
Conditions
Interventions
The study is a parallel, stratified, randomised controlled trial. This protocol involves recruitment via a physician or the Woolcock Institute volunteer database, a 4-week run-in period where allergen exposure and symptoms are monitored to determine that the subject complies with the entry criteria. Subjects are then allocated, using a randomised block design, stratified for allergen exposure, to parallel interventions involving either multiple allergen avoidance methods (this includes bed encas
The study is a parallel, stratified, randomised controlled trial. This protocol involves recruitment via a physician or the Woolcock Institute volunteer database, a 4-week run-in period where allergen exposure and symptoms are monitored to determine that the subject complies with the entry criteria. Subjects are then allocated, using a randomised block design, stratified for allergen exposure, to parallel interventions involving either multiple allergen avoidance methods (this includes bed encasings from Mite-GuardTM, Sunbeam HEPA air filter and frequent washing using the acaracide Acaril) or conventional pharmacotherapy (using Nasonex®, i.e. mometasone furoate) for 8 weeks. Twenty subjects are to be completed before early September.
Sponsors
niversity of Sydney (Pharmacology Department)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Physician-diagnosed, persistent allergic rhinitis. Mite allergic (SPT wheal >2mm than +ve histamine control). Have >75% of their total domestic mite allergen exposure while in bed. Have daily symptoms of rhinitis that will enable an improvement to be measured. No asthma, or have only mild to moderate asthma (as classified by Physician). Willing, able and otherwise suitable to participate and perform the required interventions.
Exclusion criteria
Existing daily use of oral or topical intra-nasal corticosteroids. Severe asthma (as classified by Physician). Have an existing combination of allergies to other (non-mite) domestic allergens and associated exposure to these allergens that may compromise the effectiveness of the planned intervention directed at mite allergen exposure. For example, being cat allergic and being exposed to a cat at home would serve to exclude, as the intervention in beds cannot control cat allergen exposure in the house. However if there is cat allergy but no cat exposure, or cat exposure but no cat allergy, then this is not grounds for exclusion. Pregnancy. Current or recent history of a purulent nasal infection. Nasal Polyps. Exclusion criteria for the medication include tuberculosis, herpes simplex of the eye, recent nasal surgery or untreated nasal infections. Complete nasal obstruction.
Outcome results
None listed