Effects of waterfall aerosol on paediatric allergic asthma

ISRCTN	ISRCTN04002573
DOI	https://doi.org/10.1186/ISRCTN04002573
Secondary identifying numbers	415-E786/4-2007

Submission date: 28/11/2011
Registration date: 23/12/2011
Last edited: 14/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Arnulf Hartl
Scientific

Billrothstr. 11
Salzburg
5020
Austria

Phone	+43 69 9144 20022
Email	arnulf.hartl@pmu.ac.at

Study information

Study design	Randomized controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effects of waterfall aerosol on paediatric allergic asthma: a randomized controlled trial
Study objectives	Does ionized waterfall aerosol have an effect on clinical, functional and immunological parameters of pediatric allergic asthma?
Ethics approval(s)	Ethics Comission, Salzburg [Ethikkommission für das Bundesland Salzburg], 3 December 2007, ref: 415-E786/4-2007
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2007
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	60
Total final enrolment	54
Key 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
Key exclusion criteria	1. Systemic corticosteroids 2. Severe uncontrolled asthma
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Austria
Bosnia and Herzegovina
Germany

Study participating centre

Billrothstr. 11

Salzburg
5020
Austria

Sponsor information

Austrian Research Promotion Agency [Österreichische Forschungsförderungsgesellschaft mbH (FFG)] (Austria)
Research organisation

Sensengasse 1
Wien
1090
Austria

Website	http://www.ffg.at
"ROR"	https://ror.org/028jc0449

Funders

Funder type

Research organisation

Austrian Research Promotion Agency [Österreichische Forschungsförderungsgesellschaft mbH (FFG)] (Austria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/10/2012	14/04/2022	Yes	No

Editorial Notes

14/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.