severe refractory asthma
Conditions
Interventions
Treatment consists of an intensive pulmonary multidisciplinary rehabilitation program either in the high altitude asthma centre in Davos or in a tertiary lung centre (Heideheuvel) in The Netherlands.
self-management
physical fitness
functional-ADL-training, dyspnoea management
food and diet
coping
problems in family interactions) which all patients receive and 24 additional modules for which specific inclusion criteria are described in the DBC.
Sponsors
Merem Behandelcentra
Eligibility
Inclusion criteria
Inclusion criteria: Adult subjects with asthma, requiring treatment with guideline suggested medications for GINA steps 4 – 5 asthma (receiving inhaled CS (≥500 μg fluticasone or equivalent) and LABA as maintenance therapy) for the previous year or systemic CS ≥6 months / year, that remain ‘‘uncontrolled’’ despite this therapy, for which multidisciplinary pulmonary rehabilitation in a tertiary lung centre is indicated. Uncontrolled asthma is defined by the presence of at least one of the following criteria: 1) poor symptom control: ACQ consistently >1.5, ACT 3 days each) in the previous year 3) serious exacerbations: at least one hospitalisation, ICU stay or mechanical ventilation in the previous year 4) airflow limitation: after appropriate bronchodilator withhold postbronchodilator FEV1 <80% of predicted (in the face of a reduced FEV1 / FVC, defined as FEV1 / FVC z-score <1.64). Additional inclusion criteria are: 1) age ≥18 and <75 years 2) inhaler technique is optimized 3) adherence to asthma medication is optimized 4) environmental control measures to limit exposure to allergens are taken 5) optimal treatment of comorbidity 6) no medication which can aggravate asthma 7) patient is a non-smoker or stopped smoking at least 6 months before study entry 8) patient has been treated by a pulmonologist in the past 6 months
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study if he / she: 1)participated in a clinical trial in the preceding three months 2)has known alcohol abuse or a severe unstable psychiatric condition requiring treatment 3)has unstable cardiovascular status 4)is pregnant or planning to become pregnant; 5)suffers from other lung disease that impact on asthma symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma-specific Quality of Life assessed with the The 32-item Asthma Quality of Life Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) the Asthma Control Questionnaire (ACQ) 2) medication use: daily oral and inhaled glucocorticoid dose 3) 6-min walk test 4) markers of systemic and airway inflammation: eosinophils in peripheral blood; Exhaled nitric oxide fraction (FeNO) 5) Pulmonary Function Testing 6) The rhino-sinusitis health status, assessed with the 20-question Sino-Nasal Outcome Test (SNOT-20) 7) The Nijmegen Clinical Screening Instrument (NCSI): to detect the problems in health status on individual patient base. 8) asthma-related healthcare resource utilization 9) number of work or school / college days missed due to asthma. 10)Global perceived effect (rated on a seven-point Likert scale) | — |
Contacts
Public ContactProf.J-W. J. Lammers MD PhD Lammers
UMC Utrecht, Department of Respiratory Medicine Heidelberglaan 100, 3584 CX, Utrecht The Netherlands
Outcome results
None listed