Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000095561
Ethics application status
Approved
Date submitted
3/03/2006
Date registered
9/03/2006
Date last updated
9/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
“Sleep disturbances in subjects with asthma and rhinitis”
Scientific title
" A double blind, randomised, placebo controlled, cross-over, intervention study evaluating the effect of treating rhinitis in asthma with intranasal steroids to improve sleep.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rhinitis in Asthma 1060 0
Condition category
Condition code
Respiratory 1140 1140 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 weeks of intranasal Fluticasone spray 400 ug daily
Intervention code [1] 913 0
Treatment: Drugs
Comparator / control treatment
6 weeks of intranasal placebo spray
Control group
Placebo

Outcomes
Primary outcome [1] 1532 0
Health related quality of life will be measured with the rhinitis specific questionnaire "Rhinitis quality of life questionnaire" (RQLQ).
Timepoint [1] 1532 0
Measured at the start of each treatment period and at the end of each treatment period
Primary outcome [2] 1533 0
Subjective sleep will be evaluated with the "Epworth sleeping scale"
Timepoint [2] 1533 0
Measured at the start of each treatment period and at the end of each treatment period
Secondary outcome [1] 2770 0
Nocturnal limbmovements measured with actimetry.
Timepoint [1] 2770 0
Measured at the start of each treatment period and at the end of each treatment period.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
An independent operator prepares number containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1245 0
Other
Name [1] 1245 0
Academic study The Woolcock Institute
Country [1] 1245 0
Australia
Primary sponsor type
Other
Name
The Woolcock Institute
Address
Country
Australia
Secondary sponsor category [1] 1100 0
University
Name [1] 1100 0
The Sahlgrenska Academy, Gothenburgh, Sweden
Address [1] 1100 0
Country [1] 1100 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2579 0
Sydney South West Area Health Service, Royal Prince Alfred Hospital
Ethics committee address [1] 2579 0
Ethics committee country [1] 2579 0
Australia
Date submitted for ethics approval [1] 2579 0
Approval date [1] 2579 0
05/12/2005
Ethics approval number [1] 2579 0
X05-0282

Summary
Brief summary
A majority of patients with asthma has nasal inflammation but it is not always diagnosed and treated. Nasal inflammation cause sleep disturbances that can be improved by treatment with nasal steroid spray. It has not been studied before if treatment with nasal steroids can improve sleep in patients with asthma. We will investigate 30 patients with asthma to see if their "quality of sleep" and "quality of life" can be improved by treament with nasal steroid spray compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36037 0
Address 36037 0
Country 36037 0
Phone 36037 0
Fax 36037 0
Email 36037 0
Contact person for public queries
Name 10102 0
Johan Hellgren
Address 10102 0
The Woolcock Institute for Medical Research
University of Sydney
Blackburn Building
Room 461
Camperdown NSW 2050
Country 10102 0
Australia
Phone 10102 0
+61 2 93514145
Fax 10102 0
Email 10102 0
[email protected]
Contact person for scientific queries
Name 1030 0
Janet Rimmer
Address 1030 0
806/438 Victoria St
Darlinghurst NSW 2010
Country 1030 0
Australia
Phone 1030 0
+61 2 83826822
Fax 1030 0
Email 1030 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.