ISRCTN ISRCTN86717853
DOI https://doi.org/10.1186/ISRCTN86717853
Secondary identifying numbers N/A
Submission date
07/11/2005
Registration date
28/11/2005
Last edited
07/01/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Clare Murray
Scientific

North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone +44 (0)161 291 4199
Email cmurray@fs1.with.man.ac.uk

Study information

Study designA randomized double blind placebo controlled study investigating the effects of early intervention with low dose inhaled corticosteroids (fluticasone propionate) in young children with wheeze
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymIFWIN
Study objectives1. 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?
Ethics approval(s)ERP/97/023, 21st April 1997
Health condition(s) or problem(s) studiedAsthma in children
InterventionLow dose inhaled corticosteroids (fluticasone propionate) versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fluticasone propionate
Primary outcome measure1. 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 measures1. Rescue and added asthma medication
2. Number of exacerbations
3. Safety parameters – length/height, weight
4. Symptom scores
5. Adrenal function
Overall study start date01/05/1997
Completion date31/03/2003

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit4 Years
SexBoth
Target number of participants200
Key inclusion criteria1. Children aged 6 months to 4 years
2. Two episodes of doctor verified wheeze or one episode continuous for more than 4 weeks
Key exclusion criteria1. 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
Date of first enrolment01/05/1997
Date of final enrolment31/03/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North West Lung Research Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

Wythenshawe Hospital (UK)
Hospital/treatment centre

Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom

Phone +44 (0)161 291 5775
Email amaines@fs1.with.man.ac.uk
ROR logo "ROR" https://ror.org/05vpsdj37

Funders

Funder type

Industry

GlaxoSmithKline (UK)
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 26/08/2006 Yes No