Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/02/2010
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 S H Arshad

ORCID ID

Contact details

Asthma and Allergy Research Centre
St Mary's Hospital
Isle of Wight
Newport
PO30 5TG
United Kingdom
+44 (0)1983 822928
sha@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPGS788

Study information

Scientific title

Acronym

Study hypothesis

In infants genetically predisposed to atopy, allergen exposure in infancy plays a critical role in the development of phenotypic manifestations. Allergen avoidance in this period leads to a reduction in the prevalence of asthma, other allergic disorders and/or skin sensitisation.

Ethics approval

Added 08/02/10: The Isle of Wight Local Research Ethics Committee approved on the 23rd of December 1997 (ref: 35/97)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

Asthma

Intervention

Reduced allergen exposure (food and aero-allergen) in prophylactic group

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Two questionnaires to assess symptoms suggestive of allergic diseases
2. Physical examination
3. Skin prick tests
4. Pulmonary function tests and bronchial challenges
5. Total serum IgE
6. Aero-allergen screen

Secondary outcome measures

None

Overall trial start date

01/05/1998

Overall trial end date

01/05/2000

Reason abandoned

Eligibility

Participant inclusion criteria

120 infants with high risk of atopy recruited antenatally, now aged 8 yrs

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/05/1998

Recruitment end date

01/05/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Asthma and Allergy Research Centre
Newport
PO30 5TG
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12775858
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17291851

Publication citations

  1. Results

    Arshad SH, Bateman B, Matthews SM, Primary prevention of asthma and atopy during childhood by allergen avoidance in infancy: a randomised controlled study., Thorax, 2003, 58, 6, 489-493.

  2. Results

    Arshad SH, Bateman B, Sadeghnejad A, Gant C, Matthews SM, Prevention of allergic disease during childhood by allergen avoidance: the Isle of Wight prevention study., J. Allergy Clin. Immunol., 2007, 119, 2, 307-313, doi: 10.1016/j.jaci.2006.12.621.

Additional files

Editorial Notes