Plain English Summary
Background and study aims
Allergic asthma is the most common type of asthma, affecting both children and adults. It is correlated with allergies in about 90 % of children and about 50 % of adults. It is a complex disease with a strong genetic component, and it is characterized by recurrent episodes of wheezing, variable airway obstruction and bronchial hyper-reactivity (BHR).
Based on historical tradition and on observations, it has been suggested that waterfall aerosols may help fight paediatric allergic asthma. So far, this question has not been investigated and this is the aim of this study.
Who can participate?
Male/female children aged 8-15 years with mild to moderate persistent asthma according to GINA guidelines. Minimum medication to achieve adequate asthma control with inhaled corticosteroids and beta-sympathomimetics on demand.
What does the study involve?
Asthmatic allergic children will spend three weeks in an alpine asthma camp in the summer months of July and August in the village of Krimml (Austria). Half of the group will be exposed to the Krimml waterfall for one hour per day, whereas the other half will spend the same time at a control site without waterfall exposure. A number of tests will be carried out.
What are the possible benefits and risks of participating?
Benefits include improvements due to well described health effects of high altitude on asthma. The risks for the patients are comparable to a three weeks summer holiday in the Alps.
Where is the study run from?
The lead centre is the Laboratory of Translational Immuno-research of the Paracelsus Medical University Salzburg in cooperation with local medical doctors in the region of Salzburg/Pinzgau (Austria).
When is the study starting and how long is it expected to run for?
The study ran between July 2007 and December 2008.
Who is funding the study?
The study is funded by the Oesterreichische Forschungsfoerderungsgesellschaft (FFG) and the state province of Salzburg (Austria).
Who is the main contact?
Dr Arnulf Hartl
arnulf.hartl@pmu.ac.at
Trial website
Contact information
Type
Scientific
Primary contact
Dr Arnulf Hartl
ORCID ID
Contact details
Billrothstr. 11
Salzburg
5020
Austria
+43 69 9144 20022
arnulf.hartl@pmu.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
415-E786/4-2007
Study information
Scientific title
Effects of waterfall aerosol on paediatric allergic asthma: a randomized controlled trial
Acronym
Study hypothesis
Does ionized waterfall aerosol have an effect on clinical, functional and immunological parameters of pediatric allergic asthma?
Ethics approval
Ethics Comission, Salzburg [Ethikkommission für das Bundesland Salzburg], 3 December 2007, ref: 415-E786/4-2007
Study design
Randomized controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asthma bronchiole
Intervention
Intervention: Climate therapy (Asthma Camp in the Alps) at the site of a waterfall 1 hour in the day
Control: Climate therapy (Asthma Camp in the Alps) not at the site of a waterfall 1 hour in the day
Total duration: 3 weeks Asthma Camp
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Symptome score - Asthma control test (ACT) at day 1,11,19,50,80,140
2. Lung function (spirometry at day 0,3,7,9,11,13,15,17,19,20,80)
3. Exhaled nitrix oxide (NO) (FeNO) at day 0,10,14,18,20,80
Secondary outcome measures
Immunological parameters of allergic inflammation (blood collection at day 1, 20)
Overall trial start date
01/01/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male/female children aged 8-15 years with mild to moderate persistent asthma according to Global Initiative on Asthma (GINA) guidelines
2. Minimum medication to achieve adequate asthma control with inhaled corticosteroids and beta-sympathomimetics on demand
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Systemic corticosteroids
2. Severe uncontrolled asthma
Recruitment start date
01/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Austria, Bosnia and Herzegovina, Germany
Trial participating centre
Billrothstr. 11
Salzburg
5020
Austria
Sponsor information
Organisation
Austrian Research Promotion Agency [Österreichische Forschungsförderungsgesellschaft mbH (FFG)] (Austria)
Sponsor details
Sensengasse 1
Wien
1090
Austria
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Austrian Research Promotion Agency [Österreichische Forschungsförderungsgesellschaft mbH (FFG)] (Austria)
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
Basic results (scientific)
Publication list