Condition category
Respiratory
Date applied
07/11/2005
Date assigned
28/11/2005
Last edited
07/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clare Murray

ORCID ID

Contact details

North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 4199
cmurray@fs1.with.man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

IFWIN

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?

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Asthma in children

Intervention

Low dose inhaled corticosteroids (fluticasone propionate) versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Fluticasone propionate

Primary outcome measures

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 measures

1. Rescue and added asthma medication
2. Number of exacerbations
3. Safety parameters – length/height, weight
4. Symptom scores
5. Adrenal function

Overall trial start date

01/05/1997

Overall trial end date

31/03/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/05/1997

Recruitment end date

31/03/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West Lung Research Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Wythenshawe Hospital (UK)

Sponsor details

Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5775
amaines@fs1.with.man.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (UK)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16935686

Publication citations

  1. Results

    Murray CS, Woodcock A, Langley SJ, Morris J, Custovic A, , Secondary prevention of asthma by the use of Inhaled Fluticasone propionate in Wheezy INfants (IFWIN): double-blind, randomised, controlled study., Lancet, 2006, 368, 9537, 754-762, doi: 10.1016/S0140-6736(06)69285-4.

Additional files

Editorial Notes