Condition category
Skin and Connective Tissue Diseases
Date applied
16/01/2015
Date assigned
14/03/2015
Last edited
10/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 2018

Who is funding the study?
Imperial College Biomedical Research Centre (UK)

Who is the main contact?
Dr Claudia Gore

Trial website

Contact information

Type

Public

Primary contact

Dr Claudia Gore

ORCID ID

Contact details

Dept of Paediatric Allergy
St Mary's Hospital
Imperial College Healthcare NHS Trust
Praed Street
London
W2 1NY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Temperature controlled laminar airflow treatment in children with severe atopic eczema: a pilot study

Acronym

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

Local research ethics committee (London-Fulham) number 14/LO/0130

Study design

Single centre open-label extended pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Treatment

Patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

15/01/2015

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

15

Participant exclusion criteria

Unwilling or unable to comply with the study protocol

Recruitment start date

15/01/2015

Recruitment end date

15/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College Health Care NHS Trust
London
W2 1NY
United Kingdom

Sponsor information

Organisation

Imperial College

Sponsor details

Regulatory Compliance Office
Room 510A
Level 5 Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Imperial College Biomedical Research Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Presentation at national/international meetings; publication in scientific journal; further plan to be confirmed later

Intention to publish date

01/12/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes