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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12606000095561 |
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Date of registration:
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09/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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“Sleep disturbances in subjects with asthma and rhinitis”
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Scientific title:
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" A double blind, randomised, placebo controlled, cross-over, intervention study evaluating the effect of treating rhinitis in asthma with intranasal steroids to improve sleep. |
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Date of first enrolment:
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10/03/2006 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12606000095561.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
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Phase:
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Phase 1 / Phase 2
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Countries of recruitment
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Australia
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Contacts
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Name:
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Johan Hellgren
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Address:
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The Woolcock Institute for Medical Research
University of Sydney
Blackburn Building
Room 461
Camperdown NSW 2050
Australia |
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Telephone:
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+61 2 93514145 |
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Email:
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johanh@med.usyd.edu.au |
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Affiliation:
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Name:
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Janet Rimmer
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Address:
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806/438 Victoria St
Darlinghurst NSW 2010
Australia |
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Telephone:
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+61 2 83826822 |
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Email:
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Jrimmer@woolcock.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Previous studies show that nearly 100% of patients with asthma also have a nasal inflammation (rhinitis) as part of their generalised airway inflammation, but not all asthma patients have symptoms from their nose. This study, however, evaluates if antiinflammatory treatment of the nose have an effect on sleep, regardless of nasal symptoms or not.Inclusion: medically diagnosed asthma.
Exclusion criteria: Pre-existing treatment with nasal steroids which is not able to be stoppedKnown obstructive sleep apnoea syndrome (OSAS)Treatment with oral steroidsPrevious hospitalisation (within the last 12 months) for asthmaInhaled steroid dosage exceeding 1000µg/day (fluticasone) or 1600ug/day (budesonide)Treatment with sedativesTreatment with neuroleptic pharamceuticalsNasal polypsSevere septal deviation or turbinate hypertrophy.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Respiratory - Asthma
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Rhinitis in Asthma;
Rhinitis in Asthma
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Intervention(s)
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6 weeks of intranasal Fluticasone spray 400 ug daily
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Primary Outcome(s)
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Health related quality of life will be measured with the rhinitis specific questionnaire "Rhinitis quality of life questionnaire" (RQLQ).[Measured at the start of each treatment period and at the end of each treatment period]
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Subjective sleep will be evaluated with the "Epworth sleeping scale"[Measured at the start of each treatment period and at the end of each treatment period]
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Secondary Outcome(s)
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Nocturnal limbmovements measured with actimetry.[Measured at the start of each treatment period and at the end of each treatment period.]
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Source(s) of Monetary Support
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Academic study The Woolcock Institute
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Ethics review
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Status: Approved
Approval date:
Contact:
Sydney South West Area Health Service, Royal Prince Alfred Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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