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Inhaled Fluticasone in Wheezy Infants
ISRCTN ISRCTN86717853
DOI 10.1186/ISRCTN86717853
ClinicalTrials.gov identifier
EudraCT number
Public title Inhaled Fluticasone in Wheezy Infants
Scientific title
Acronym IFWIN
Serial number at source N/A
Study hypothesis 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?
Lay summary
Ethics approval ERP/97/023, 21st April 1997
Study design 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
Countries of recruitment United Kingdom
Disease/condition/study domain Asthma in children
Participants - inclusion criteria 1. Children aged 6 months to 4 years
2. Two episodes of doctor verified wheeze or one episode continuous for more than 4 weeks
Participants - exclusion criteria 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
Anticipated start date 01/05/1997
Anticipated end date 31/03/2003
Status of trial Completed
Patient information material
Target number of participants 200
Interventions Low dose inhaled corticosteroids (fluticasone propionate) versus placebo
Primary outcome measure(s) 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
Secondary outcome measure(s) 1. Rescue and added asthma medication
2. Number of exacerbations
3. Safety parameters length/height, weight
4. Symptom scores
5. Adrenal function
Sources of funding GlaxoSmithKline (UK)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16935686
Contact name Dr  Clare  Murray
  Address North West Lung Research Centre

Wythenshawe Hospital

Southmoor Road
  City/town Manchester
  Zip/Postcode M23 9LT
  Country United Kingdom
  Tel +44 (0)161 291 4199
  Fax +44 (0)161 291 5057
  Email cmurray@fs1.with.man.ac.uk
Sponsor Wythenshawe Hospital (UK)
  Address Andrew Maines

R&D Directorate

ERC Building

Wythenshawe Hospital

Southmoor Road
  City/town Manchester
  Zip/Postcode M23 9LT
  Country United Kingdom
  Tel +44 (0)161 291 5775
  Fax +44 (0)161 291 5771
  Email amaines@fs1.with.man.ac.uk
Date applied 07/11/2005
Last edited 07/01/2008
Date ISRCTN assigned 28/11/2005
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