Temperature controlled airflow (air shower) treatment in children with severe skin allergy
| ISRCTN | ISRCTN65865773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65865773 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/01/2015
- Registration date
- 14/03/2015
- Last edited
- 02/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Tiny particles in the air that cause allergies such as dust mite and pollen or those from cats and pollutants from traffic exhaust fumes can lead to health problems. Avoidance of these tiny particles can improve health. Unfortunately, complete avoidance of these particles inside the home is often not possible. In this study, we shall test a new treatment called Airsonett, for removing these particles in the air, on children.
Who can participate?
Children aged 2–16 years old with severe skin allergies
What does the study involve?
Airsonett will be installed in the rooms of participants, so that they are surrounded by clean and slightly cooler air while they are sleeping.
What are the possible benefits and risks of participating?
A benefit is the avoidance of particles in the air that cause allergies. Risks were not provided at the time of registration.
Where is the study run from?
Imperial College Health Care NHS Trust (UK)
When is the study starting and how long is it expected to run for?
From January 2015 to December 2025
Who is funding the study?
Imperial College Biomedical Research Centre (UK)
Who is the main contact?
Dr Claudia Gore
Contact information
Public
Dept of Paediatric Allergy
St Mary's Hospital
Imperial College Healthcare NHS Trust
Praed Street
London
W2 1NY
United Kingdom
Study information
| Study design | Single centre open-label extended pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Scientific title | Temperature controlled laminar airflow treatment in children with severe atopic eczema: a pilot study |
| Study hypothesis | Temperature controlled laminar airflow (TLA) treatment improves severe eczema in children, leading to reduced health care use, better sleep and quality of life |
| Ethics approval(s) | Local research ethics committee (London-Fulham) number 14/LO/0130 |
| Condition | 1. Severe atopic eczema, treatment resistant or dependent on potent topical/systemic therapy 2. Most participants will have multiple allergic comorbidities, such as allergic rhino conjunctivitis, asthma and food allergies |
| Intervention | 1. A TLA device (Airsonett) will be installed for all participants 2. Airsonett is a European Union registered medical device and has been approved in the United Kingdom for use by consumers; it produces highly filtered clean air that is 0·5°C cooler than the rest of the air in the room; this cooler air surrounds individual while he or she is sleeping and filters the tiny particles and allergens in their breathing zone (i.e., the air a person would breathe in) during sleep 3. In the week before and after the installation of the TLA device, aeroallergen sampling will take place and a novel home sleep-study device will be in place to assess changes in sleep quality 4. Participants will have detailed clinical follow-up |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | Improvement in sleep and pruritus (SCORAD-C, visual analogue score) Measured at 1 month, 3 months, 6 months, 12 months. |
| Secondary outcome measures | 1. Reduction in Health Care Utilisation 2. Cost score combining medication requirement and unscheduled healthcare visits 3. Improvement in eczema related quality of life (validated questionnaires: CDQoL, FDI) 4. Change in allergen exposure during TLA use in home environment (particle counting, airsampling) 5. Improvement in rhinitis related quality of life. (Paed RQLQ) 6. Change in sleep quality as assessed by home sleep study (Sonomat) All Outcomes measured at 1 month, 3 months, 6 months, 12 months. Except: 1. Sonomat Outcome, measured at 3-4 days post treatment start. 2.Change in allergen exposure, measured at 3-4 days post treatment start. |
| Overall study start date | 15/01/2015 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 15 |
| Participant inclusion criteria | 1. Age 2–16 years old 2. Severe atopic eczema and evidence of sensitization to at least one perennial allergen (house dust mite, pets or mould 3. Consent to participate voluntarily and parental consent if participant is younger than 16 years old 4. Willing and able to comply with the study specific procedures; signed informed consent needed before any study procedure 5. Sufficient space to install the TLA device in the home |
| Participant exclusion criteria | Unwilling or unable to comply with the study protocol |
| Recruitment start date | 15/01/2015 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W2 1NY
United Kingdom
Sponsor information
University/education
Regulatory Compliance Office
Room 510A
Level 5 Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Presentation at national/international meetings; publication in scientific journal; further plan to be confirmed later |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2018 | 01/10/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
02/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/01/2016 to 31/12/2024.
2. The overall end date was changed from 31/12/2023 to 31/12/2025.
3. The intention to publish date was changed from 01/12/2016 to 31/12/2026.
05/10/2022: The overall trial end date was changed from 31/12/2018 to 31/12/2023.
13/03/2020: Internal review.
01/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
