Effect of allergen avoidance in infancy on airway inflammation
| ISRCTN | ISRCTN28233205 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28233205 |
| Secondary identifying numbers | 7489 |
- 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
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
| Study design | Single centre randomised interventional prevention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2009 |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Planned sample size: 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
- England
- United Kingdom
Study participating centre
St Mary's Hospital IOW
Newport
PO30 5TG
United Kingdom
PO30 5TG
United Kingdom
Sponsor information
Isle of Wight Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
St. Marys Hospital
Parkhurst Road
Newport
PO30 5TG
England
United Kingdom
| Website | http://www.iow.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/013aa1717 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
