|- candidate number||3200|
|- NTR Number||NTR1277|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-apr-2008|
|- Secondary IDs||07/206 MEC |
|- Public Title||Difficult to treat asthma at high altitude|
|- Scientific Title||Clinical and pathophysiological features of difficult to treat asthma at high altitude.|
|- ACRONYM||Difficult to treat asthma at high altitude|
|- Healt Condition(s) or Problem(s) studied||Asthma, High altitude treatment, Pathophysiology, Severe asthma|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-sep-2007|
|- planned closingdate||1-dec-2011|
|- Target number of participants||150|
|- Interventions||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.
|- 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.|
|- Timepoints||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.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Lous H.M. Rijssenbeek-Nouwens|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Elisabeth H.D. Bel|
|- Sponsor/Initiator ||Nederlands Astmacentrum Davos, NAD|
(Source(s) of Monetary or Material Support)
|Vereniging Nederland Davos , Nederlands Astmacentrum Davos, NAD|
|- Publications||- Bel, E. H. 2004. Clinical phenotypes of asthma. Curr.Opin.Pulm.Med. 10:44-50. |
- 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.
- 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.
|- Brief 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?
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.
|- Main changes (audit trail)|
|- RECORD||14-apr-2008 - 17-mei-2008|