No registrations found.
Source
Brief title
Health condition
Difficult to treat asthma
Phenotypes of severe asthma
Clinical features
Pathophysiology
High altitude treatment
Moeilijk te behandelen astma
Fenotypen van ernstig astma
Klinische kenmerken
Pathofysiologie
Hooggebergte behandeling
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Improvement in Asthma-control (ACQ) and FEV1 and decrease in mean oral steroid maintenance dose.
Secondary outcome
Improvement in Asthma related Quality of Life (AQLQ), rhinosinusitis score (RSOM-31) fatique score (CIS-Fatique), body mass index (BMI), residual volume as percentage of total lung capacity (RV/TLC), exhaled nitric oxide (FeNO), changes in levels of 25-hydroxyvitamin D and 1.25-(OH)2 vitamin D.
Background summary
Background: Patients with difficult-to treat asthma remain symptomatic despite the use of high doses of currently available medication. They have greater morbidity,and poorer quality of life than patients with milder forms of the disease, and consume a disproportionate amount of healthcare resources for asthma. Patients with difficult-to-treat asthma form a heterogeneous group, and phenotyping is necessary in order to increase our understanding of the disease and develop novel treatments. Interesting, a proportion of patients with difficult-to-treat asthma seem to improve during treatment at high altitude. However the characteristics of these patients and the mechanisms by which they improve are still largely unknown.
Objective of the study:
1. Can difficult-to-treat asthma be divided in different phenotypes with different responses to high altitude treatment?
2. Are there specific markers or clinical characteristics in patients with difficult-to-treat asthma that predict the short term and longterm effect of high altitude treatment?
3. Is the response to high altitude treatment associated with changes in the level of activated vitamin D?
Study design:
In this longitudinal, prospective, 15 months follow up study, the patients will be assessed at entry and after 6 and 12 weeks of a standard rehabilitation programme at high altitude in the Dutch Asthmacentre Davos, and thereafter at discharge, and dutring 12 months at sea level at 3-monthly intervals.
Study design
15 months follow up study
Patients will be assessed at entry and after 6 and 12 weeks of a standard rehabilitation programme at high altitude in the Dutch Asthmacentre Davos, and thereafter at discharge, and dutring 12 months at sea level at 3-monthly intervals.
Intervention
Integrated multidisciplinary assesment of the asthma-control status, asthma history, asthma specific health status,
co-morbidity, asthma- triggering factors, medication need, lungfunction,
inflammation markers and excercise tolerance.
The pulmonary rehabilitation, according to ERS guidelines, will be adjusted to this integrated assessed profile of the patient in the allergen and pollutionfree high altitude climate in Davos with low relative humidity during 12 weeks.
HermanBurckhartstrasse 7260
Lous H.M. Rijssenbeek-Nouwens
[default]
Switzerland
0041 814178000
lrijssenbeek@nad.ch
HermanBurckhartstrasse 7260
Lous H.M. Rijssenbeek-Nouwens
[default]
Switzerland
0041 814178000
lrijssenbeek@nad.ch
Inclusion criteria
1. Age 18-80 year
2. Difficult to treat asthma, defined as uncontrolled asthma despite the chronic use of > 1600 mcg inhaled beclomethason equivalent plus longacting beta-2 agonists or oral steroids.
3. Smoking history < 15 years, or reversibility in FEV1 to short acting beta agonist > 9%.
Exclusion criteria
Exclusion for treatment in Davos:
1. Active cardio-vascular disease
2. Active and acute psychiatric disease in need of treatment by a psychiatrist.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1232 |
NTR-old | NTR1277 |
Other | MEC : 07/206 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
- Rijssenbeek-Nouwens LH, Bron AO, Naves C, Weller F, Weersink EJ, and Bel EH. Persistent airflow limitation in severe asthma is not an irreversible phenomenon. Proceedings of the American Thoracic Society 3 (abstract issue), A580. 2006. <br>
- Grootendorst, D. C., S. E. Dahlen, J. W. Van Den Bos, E. J. Duiverman, M. Veselic-Charvat, E. J. Vrijlandt, S. O'Sullivan, M. Kumlin, P. J. Sterk, and A. C. Roldaan. 2001. Benefits of high altitude allergen avoidance in atopic adolescents with moderate to severe asthma, over and above treatment with high dose inhaled steroids. Clin.Exp.Allergy. 31:400-408.