Condition category
Respiratory
Date applied
28/11/2011
Date assigned
23/12/2011
Last edited
31/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 week’s 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 measures

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

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

http://www.ffg.at

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes