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
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
-
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.
-
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.