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Trial registered on ANZCTR


Registration number
ACTRN12605000513617
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
26/09/2005
Date last updated
26/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
COMPARISON OF INTRANASAL CORTICOSTEROIDS WITH ALLERGEN AVOIDANCE FOR THE MANAGEMENT OF PERSISTENT RHINITIS
Scientific title
COMPARISON OF INTRANASAL CORTICOSTEROIDS WITH ALLERGEN AVOIDANCE FOR THE MANAGEMENT OF PERSISTENT RHINITIS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Allergic Rhinitis 638 0
Condition category
Condition code
Inflammatory and Immune System 711 711 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 614 0
Prevention
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 866 0
1. That mite allergen avoidance methods can provide marked reduction in total inhaled exposure to allergens if the allergen removal practices are frequent and aggressive and if they address both reservoirs of allergens and aeroallergens
Timepoint [1] 866 0
Allergen levels measured every fortnight.
Primary outcome [2] 867 0
2. Such reductions in nocturnal exposure would improve symptoms of persistent rhinitis in subjects for whom mite allergens are their major allergen exposure.
Timepoint [2] 867 0
Symptom diaries measured daily.
Primary outcome [3] 868 0
3. That pharmacotherapy can also provide effective management of rhinitis.
Timepoint [3] 868 0
Symptom diaries measured daily.
Secondary outcome [1] 1734 0
Both forms of management provide different time courses for the relief of symptoms (daily symptom diaries) and in the longer term, raise different issues of patient compliance and satisfaction with the treatment (compliance and satisfaction measured at the end of treatment using questionnaires).
Timepoint [1] 1734 0

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Patient names were placed into sealed envelopes and then randomly allocated into either arm of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss; blocking
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
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)

Funding & Sponsors
Funding source category [1] 787 0
University
Name [1] 787 0
University of Sydney (Pharmacology Department)
Address [1] 787 0
Country [1] 787 0
Australia
Primary sponsor type
University
Name
niversity of Sydney (Pharmacology Department)
Address
Country
Australia
Secondary sponsor category [1] 651 0
Other
Name [1] 651 0
Woolcock Institute of Medical Research
Address [1] 651 0
Country [1] 651 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36083 0
Address 36083 0
Country 36083 0
Phone 36083 0
Fax 36083 0
Email 36083 0
Contact person for public queries
Name 9803 0
Ms Wendy Taylor
Address 9803 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9803 0
Australia
Phone 9803 0
+61 2 95156578
Fax 9803 0
+61 2 95505865
Email 9803 0
volunteers@woolcock.org.au
Contact person for scientific queries
Name 731 0
Ms Ana Acevska
Address 731 0
Woolcock Institute of Medical Research
University of Sydney
Level 4
Blackburn Building D06
NSW 2006
Country 731 0
Australia
Phone 731 0
+61 2 93512093
Fax 731 0
+61 2 93517451
Email 731 0
aace3530@mail.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary