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ISRCTN
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ISRCTN86717853
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ClinicalTrials.gov identifier
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Public title
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Inhaled Fluticasone in Wheezy Infants
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Scientific title
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Acronym
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IFWIN
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Serial number at source
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N/A
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Study hypothesis
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1. Can the early introduction of inhaled corticosteroids (ICS) prevent the progressive fall in lung function seen in asthmatics?
2. Can early introduction of inhaled corticosteroids in children with asthma modify the natural history of the disease or prevent recurrence of asthma later in life?
3. Does treatment with ICS reduce symptoms in non-asthmatic wheezy children and improve their lung function at age 6 years?
4. Do inhaled corticosteroids improve the quality of life of families with wheezing children?
5. Is continuous treatment with ICS at this dose in young children associated with any local or systemic side effects?
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Lay summary
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Ethics approval
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ERP/97/023, 21st April 1997
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Study design
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A randomized double blind placebo controlled study investigating the effects of early intervention with low dose inhaled corticosteroids (fluticasone propionate) in young children with wheeze
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Asthma in children
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Participants - inclusion criteria
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1. Children aged 6 months to 4 years
2. Two episodes of doctor verified wheeze or one episode continuous for more than 4 weeks
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Participants - exclusion criteria
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1. Pre-term less than 34 weeks gestation
2. Neonatal lung disease or other lung disease
3. Other chronic disease
4. Children already or previously used an inhaled corticosteroid
5. Children who cannot use the spacer device
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Anticipated start date
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01/05/1997
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Anticipated end date
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31/03/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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Low dose inhaled corticosteroids (fluticasone propionate) versus placebo
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Primary outcome measure(s)
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1. Occurrence of asthma at age 5 and 6
2. Lung function at age 5
3. Non-specific bronchial hyper-reactivity at age 5
4. Number of courses and total dose of add-on fluticasone propionate required
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Secondary outcome measure(s)
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1. Rescue and added asthma medication
2. Number of exacerbations
3. Safety parameters – length/height, weight
4. Symptom scores
5. Adrenal function
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Sources of funding
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GlaxoSmithKline (UK)
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16935686
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Contact name
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Dr
Clare
Murray
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Address
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North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
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City/town
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Manchester
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Zip/Postcode
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M23 9LT
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Country
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United Kingdom
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Tel
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+44 (0)161 291 4199
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Fax
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+44 (0)161 291 5057
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Email
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cmurray@fs1.with.man.ac.uk
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Sponsor
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Wythenshawe Hospital (UK)
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Address
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Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
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City/town
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Manchester
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Zip/Postcode
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M23 9LT
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Country
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United Kingdom
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Tel
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+44 (0)161 291 5775
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Fax
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+44 (0)161 291 5771
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Email
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amaines@fs1.with.man.ac.uk
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Date applied
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07/11/2005
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Last edited
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07/01/2008
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Date ISRCTN assigned
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28/11/2005
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