Condition category
Respiratory
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
17/09/2013
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

Mr Stephen Potter

ORCID ID

Contact details

St Mary's Hospital IOW
David Hide Asthma and Allergy Research Centre
St. Marys Hospital
Parkhurst Road
Newport
PO30 5TG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7489

Study information

Scientific title

Primary prevention of asthma and atopy by allergen avoidance. Do preventative measures influence the type and degree of airway inflammation?

Acronym

Study hypothesis

Primary prevention of asthma and atopy by allergen avoidance. Do preventative measures influence the type and degree of airway inflammation?

Ethics approval

Southampton & South West Hampshire Research Ethics Committee (B) approved on the 26th November 2008 (ref: 08/H0504/184)

Study design

Single centre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Intervention

Dietary and house dust mite allergy prevention.

Sputum Induction:
This involves breathing in a mist of saline solution, which helps make phlegm in the lungs, which is then collected in a sputum pot.

Exhaled Nitric Oxide reading:
Levels will be measured using the single expiratory breath method using ATS/ERS guidelines. A bio-feedback device will be used to maintain the expiratory flow rate at 50 ml/s, subjects will exhale against a resistance to prevent upper airway contamination.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Number of sputum eosinophils in the intervention versus control group.

Sputum samples will be collected during a visit to the research centre, with preparation and analysis taking place after.

Secondary outcome measures

1. Number of other cells (1) neutrophils, (2): epithelial cells in sputum in the two groups
2. Eosinophilic inflammatory markers (eosinophilic cationic protein and interleukin 5) in sputum supernatant in the two groups

Sputum samples will be collected during a visit to the research centre, with preparation and analysis taking place after.

Overall trial start date

01/03/2009

Overall trial end date

01/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Everyone (120 subjects) who participated in the original Isle of Wight Primary Prevention study will be asked if they wish to participate.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Planned sample size: 120

Participant exclusion criteria

1. Any patient who does not wish to participate
2. Any patient where their lung function test suggests that they would be at risk of significant bronchospasm and/or clinical suspicion is high that they would not tolerate sputum induction

Recruitment start date

01/03/2009

Recruitment end date

01/02/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital IOW
Newport
PO30 5TG
United Kingdom

Sponsor information

Organisation

Isle of Wight Healthcare NHS Trust (UK)

Sponsor details

St. Marys Hospital
Parkhurst Road
Newport
PO30 5TG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.iow.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22858926

Publication citations

  1. Results

    Scott M, Roberts G, Kurukulaaratchy RJ, Matthews S, Nove A, Arshad SH, Multifaceted allergen avoidance during infancy reduces asthma during childhood with the effect persisting until age 18 years., Thorax, 2012, 67, 12, 1046-1051, doi: 10.1136/thoraxjnl-2012-202150.

Additional files

Editorial Notes