Effect of allergen avoidance in infancy on airway inflammation

ISRCTN	ISRCTN28233205
DOI	https://doi.org/10.1186/ISRCTN28233205
Protocol serial number	7489
Sponsor	Isle of Wight Healthcare NHS Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 17/09/2013

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

Mr Stephen Potter
Scientific

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

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional prevention trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Primary prevention of asthma and atopy by allergen avoidance. Do preventative measures influence the type and degree of airway inflammation?
Study objectives	Primary prevention of asthma and atopy by allergen avoidance. Do preventative measures influence the type and degree of airway inflammation?
Ethics approval(s)	Southampton & South West Hampshire Research Ethics Committee (B) approved on the 26th November 2008 (ref: 08/H0504/184)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/02/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	120
Key inclusion criteria	Everyone (120 subjects) who participated in the original Isle of Wight Primary Prevention study will be asked if they wish to participate.
Key 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
Date of first enrolment	01/03/2009
Date of final enrolment	01/02/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Mary's Hospital IOW

Newport
PO30 5TG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes