Effects of waterfall aerosol on paediatric allergic asthma
| ISRCTN | ISRCTN04002573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04002573 |
| Protocol serial number | 415-E786/4-2007 |
| Sponsor | Austrian Research Promotion Agency [Österreichische Forschungsförderungsgesellschaft mbH (FFG)] (Austria) |
| Funder | Austrian Research Promotion Agency [Österreichische Forschungsförderungsgesellschaft mbH (FFG)] (Austria) |
- 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
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
Scientific
Billrothstr. 11
Salzburg
5020
Austria
| Phone | +43 69 9144 20022 |
|---|---|
| arnulf.hartl@pmu.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Symptome score - Asthma control test (ACT) at day 1,11,19,50,80,140 |
| Key secondary outcome measure(s) |
Immunological parameters of allergic inflammation (blood collection at day 1, 20) |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 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
5020
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
