Condition category
Skin and Connective Tissue Diseases
Date applied
02/05/2013
Date assigned
22/05/2013
Last edited
20/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
About 20% of children in western European countries have atopic dermatitis (AD) (eczema), often as part of the atopic syndrome (a tendency to develop allergy). Some children continue to have symptoms despite best treatment. We want to provide new treatment options for these children. We are carrying out a study to compare two different new treatments for children with moderate to severe atopic dermatitis. Our goal is to find the most favourable treatment for children with AD. The study's findings should help to improve the quality of life of children with moderate to severe AD.

Who can participate?
Children between 8 and 18 years of age, with moderate to severe AD and asthma, from the Netherlands, can participate in this study.

What does the study involve?
In this study, two treatments are compared. One is a 6-week treatment at the outpatient clinic of the University Medical Centre, Utrecht in the Netherlands. The other is a 6-week treatment at the Dutch Asthma Centre Davos in Switzerland. The treatment that the participant will receive is decided by a process called ‘randomisation’, which is like a coin toss. After the treatment period, participants are followed up immediately after the treatment, 6 weeks and 6 months after the treatment. At these time points, we ask the participant to fill in questionnaires, blood and skin samples are taken and a lung function test is done.

What are the possible benefits and risks of participating?
Possible benefits of participating in the study are treatment for the disease, coping with the disease in a better way and improved quality of life. Long-term benefits are that new treatment will become available for all children with moderate to severe AD. There are no direct risks of participating in this study.

Where is the study run from?
The trial has been set up by the University Medical Centre, Utrecht, Netherlands in collaboration with the Dutch Asthma Centre Davos, Switzerland.

When is the study starting and how long is it expected to run for?
The study started in September 2010 and is expected to run until the summer of 2014.

Who is funding the study?
The University Medical Center Utrecht, MEREM, Vrienden van het WKZ, the European Allergy Clinic Davos and Vereniging Nederland Davos.

Who is the main contact?
Dr Suzanne Pasmans
s.pasmans@umcutrecht.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Suzanne G.M.A. Pasmans

ORCID ID

Contact details

PO Box 85090
Utrecht
3508 AB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pragmatic randomized controlled trial comparing high altitude treatment with current best care in children with moderate to severe atopic dermatitis (and asthma) in the Netherlands: multidisciplinary treatment at the high altitude clinic Dutch Asthma Centre Davos, Switzerland versus the Wilhelmina Children’s Hospital Utrecht, the Netherlands

Acronym

DAVOS

Study hypothesis

Multidisciplinary treatment for 6 weeks at the Dutch Asthma Centre Davos will improve disease coping and acceptance and quality of life of children with AD more than multidisciplinary treatment in the Wilhelmina Children’s Hospital. The null hypothesis we test is that there is no difference between the effects of both treatments.

On 03/12/2013 the following changes were made to the trial record:
1. The scientific title was changed from 'A randomised controlled trial comparing high altitude treatment with current best care in children with atopic dermatitis and asthma within the atopic syndrome in the Netherlands. Multidisciplinary treatment at the high altitude clinic Dutch Asthma Centre Davos, Switzerland versus the Wilhelmina Children’s Hospital Utrecht, the Netherlands: a national study' to 'A pragmatic randomized controlled trial comparing high altitude treatment with current best care in children with moderate to severe atopic dermatitis (and asthma) in the Netherlands: multidisciplinary treatment at the high altitude clinic Dutch Asthma Centre Davos, Switzerland versus the Wilhelmina Children’s Hospital Utrecht, the Netherlands'.
2. The anticipated end date was changed from 01/02/2015 to 01/06/2015.

Ethics approval

Medical Ethics Committee, Utrecht Medical Center, Utrecht, the Netherlands,18/12/2009, Ref: MEC 09-192-K

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Atopic dermatitis and asthma within the atopic syndrome

Intervention

Intervention: multidisciplinary treatment at the Dutch Asthma Centre in Davos, Switzerland for 6 weeks
Active control: multidisciplinary treatment at the outpatient clinic of the pediatric dermatology and allergology department at the Wilhelmina Children’s Hospital, the Netherlands for 6 weeks

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 03/12/2013:
1. Disease coping and acceptance, measured with the COPEKI/JUCCKI questionnaire
2. Disease-specific quality of life, measured with Children's Dermatology Life Quality Index (CDQLI)
3. Self Administered Eczema Area and Severity Index (SA-EASI)
All measured before the intervention, directly after the intervention, 6 weeks after the intervention and 6 months after the intervention

Previous primary outcome measures:
1. Disease coping and acceptance, measured with the COPEKI/JUCCKI questionnaire directly after the intervention and 6 months after the intervention
2. Disease-specific quality of life, measured with Children's Dermatology Life Quality Index (CDQLI) directly after the intervention, 6 weeks after the intervention and 6 months after the intervention

Secondary outcome measures

Current secondary outcome measures as of 03/12/2013:
1. Disease activity and disease control (for AD and asthma), measured with
1.1. Used (topical) corticosteroids
1.2. Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
1.3. Asthma Control Questionnaire (ACQ)
1.4. Lung function test (spirometry)
1.5. Fractional exhaled Nitric Oxide (FeNO)
1.6. Used asthma medication
All measured before, directly after the intervention, 6 weeks and 6 months after the intervention
1.7. Bronchial hyperresponsiveness (metacholine provocation test)
Measured before intervention and 6 months after intervention
2. Inflammatory and immunological profile, measured with serum levels of Thymus and Activation and Regulated Chemokine (TARC), cytokine profile (Th1/Th2) and eosinophil levels.
Measured before, directly after intervention, 6 weeks and 6 months after the intervention
3. Social and emotional wellbeing of the child and quality of life of the parents, including parental stress and fear.
Measured before, directly after intervention, 6 weeks and 6 months after the intervention
4. Other:
4.1. Bacterial colonization of the skin and nose, protease activity in skin
Measured before the intervention, directly after the intervention, 6 weeks and 6 months after the intervention
4.2. Physical condition (maximal cycle ergometer test) before intervention and 6 months after the intervention
4.3. Extra appointments with the dermatologist/e-consultations/visits to the hospital are recorded during the follow-up period

Previous secondary outcome measures:
1. Disease activity and disease control (for AD and asthma), measured with
1.1. Self Administered Eczema Area and Severity Index (SAEASI)
1.2. Used (topical) corticosteroids
1.3. Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
1.4. Asthma Control Questionnaire (ACQ)
1.5. Lung function test (spirometry)
1.6. Fractional exhaled Nitric Oxide (FeNO)
1.7. Used asthma medication
All measured before, directly after the intervention, 6 weeks and 6 months after the intervention
1.8. Bronchial hyperresponsiveness (metacholine provocation test)
Measured before the intervention and 6 months after the intervention
2. Inflammatory and immunological profile, measured with serum levels of Thymus and Activation and Regulated Chemokine (TARC), cytokine profile (Th1/Th2) and eosinophil levels.
Measured before, directly after the intervention, 6 weeks and 6 months after the intervention
3. Social and emotional wellbeing of the child and quality of life of the parents, including parental stress and fear.
Measured before, directly after the intervention, 6 weeks and 6 months after the intervention
4. Other:
4.1. Bacterial colonization of the skin and nose, protease activity in skin
Measured before the intervention, directly after the intervention, 6 weeks and 6 months after the intervention
4.2. Physical condition (maximal cycle ergometer test) before intervention and 6 months after the intervention
4.3. Extra appointments with the dermatologist/e-consultations/visits to the hospital are recorded during the follow-up period

Overall trial start date

01/09/2010

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Moderate to severe atopic dermatitis
2. 8-18 years
3. Be able to speak and write in Dutch
4. Internet access and be able to use the Digital Eczema Center Utrecht
5. Willing to stay for 6 weeks in the Dutch Asthma Centre Davos

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant exclusion criteria

Current participation in another study

Recruitment start date

01/09/2010

Recruitment end date

01/06/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

PO Box 85090
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (Netherlands)

Sponsor details

Department of (Pediatric) Dermatology and Allergology
PO Box 85090
Utrecht
3508 AB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medical Center Utrecht (UMCU), Department of (Pediatric) Dermatology and Allergology, MEREM, Vrienden van het WKZ, European Allergy Clinic Davos (EACD), Vereniging Nederland-Davos (VND)

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24670079

Publication citations

  1. Protocol

    Fieten KB, Zijlstra WT, van Os-Medendorp H, Meijer Y, Venema MU, Rijssenbeek-Nouwens L, l'Hoir MP, Bruijnzeel-Koomen CA, Pasmans SG, Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial)., Trials, 2014, 15, 94, doi: 10.1186/1745-6215-15-94.

Additional files

Editorial Notes