The primary objectives are twofold: 1) to compare the effect of 12 weeks of multidisciplinary pulmonary rehabilitation in a high-altitude centre with comparable rehabilitation in a sea level centre on asthma-specific quality of life (assessed with…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Asthma-specific quality of life assessed with the Asthma Quality of life
questionnaire
Secondary outcome
1) Asthma control (self- administered questionnaire Asthma Control
Questionnaire)
2) Medication use: daily oral and inhaled glucocorticoid dose
3) Walking endurance (incremental shuttle walk test)
4) Markers of systemic and airway inflammation (eosinophils in peripheral
blood; exhaled nitric oxide fraction (FeNO)
5) Pulmonary Function Testing including reversibility.
6) Rhino-sinusitis health status (20-question Sino-Nasal Outcome Test)
7) Problems in health status (Nijmegen Clinical Screening Instrument)
8) Asthma-related healthcare resource utilization
9) Number of work or school / college days missed due to asthma.
10) Global perceived effect of pulmonary rehabilitation.
11) Care-related Quality of life
Background summary
Patients with sever asthma suffer from insufficient asthma control despite
optimal medical treatmentand and frequent exacerbations.Severe asthma has a
large impact on the patient's quality of life. In the recent guideline
*Diagnostiek en behandeling van ernstig astma, 2013* pulmonary rehabilitation
at high altitude is considered a treatment option for these patients. High
altitude treatment combines asthma treatment with exposure to a trigger poor
environment. Part of the high altitude treatment effect is attributed to
changes in environmental triggers (low humidity air, lower general air
pollution, absence of house dust mite allergen exposure and lower microbial
exposure). The Dutch asthma centre in Davos (CH) at an altitude of 1650 metres
is a tertiary asthma centre offering rehabilitation treatment to patients with
severe asthma. Despite a long history of high altitude treatment in severe
asthma, its relative short and long-term effectiveness compared to sea level
treatment is unknown due to a lack of high-quality controlled studies. The
Dutch Health Insurance Board (Zorginstituut Nederland) has commissioned a
comparative study to investigate the short and long-term effectiveness of
high-altitude pulmonary rehabilitation compared with rehabilitation at sea
level in patients with severe, refractory asthma.
Study objective
The primary objectives are twofold:
1) to compare the effect of 12 weeks of multidisciplinary pulmonary
rehabilitation in a high-altitude centre with comparable rehabilitation in a
sea level centre on asthma-specific quality of life (assessed with the Asthma
Quality of Life Questionnaire, AQLQ) in patients with severe, refractory asthma;
2) to compare the AQLQ values over a one-year period in subjects who received
12 weeks of multidisciplinary pulmonary rehabilitation in a high-altitude
centre versus rehabilitation in a sea level centre, adjusting for differences
in exposure to environmental triggers, both outdoor and indoor. Environmental
exposure will also be monitored in both the high-altitude centre and sea level
centre.
Secondary objectives are:
1) to compare the effect of 12 weeks of multidisciplinary pulmonary
rehabilitation in a high-altitude centre with the same in sea level centre(s)
on asthma control questionnaire (ACQ) and other secondary outcomes
(care-related quality of life, cardiopulmonary fitness, medication use,
pulmo-nary function and inflammation) in patients with severe, refractory asthma
2) to compare the asthma control questionnaire (ACQ) scores over a one-year
period in subjects who received 12 weeks of multidisciplinary pulmonary
rehabilitation in high-altitude or in sea level centre
3) to investigate the impact of environmental exposure to allergens, microbial
content, PM10 and NOx in the subject*s home on short and long term treatment
effectiveness
Study design
a parallel, pragmatic, clinical trial with random allocation to high-altitude
or sea level multidisciplinary pulmonary rehabilitation
Intervention
12 weeks of intensive pulmonary multidisciplinary rehabilitation either in the
high altitude centre in Davos or in a lung centre in The Netherlands. In both
centres, the rehabilitation programme is personalized by using a modular
approach with standardized treatment modules according to the DBC *Complex
longfalen (longrevalidatie)*.
Study burden and risks
The burden associated with participation consists of the assessments at
baseline, every 3 weeks of the intervention period and the follow up
assessments (3, 6, 9 and 12 months after the end of rehabilitation). Risks of
assessments are minimal as all the assessments are standard assessments within
usual care. Both treatment options for intensive pulmonary multidisciplinary
rehabilitation, at high altitude and at sea level, are recognized as part of
standard care.
Ziekenhuisweg 100
Lelystad 8233 AA
NL
Ziekenhuisweg 100
Lelystad 8233 AA
NL
Listed location countries
Age
Inclusion criteria
Adult subjects with asthma, requiring treatment with guideline suggested medications for GINA steps 4 * 5 asthma (receiving inhaled CS (*500 *g 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 <20 (or **not well controlled** by NAEPP / GINA guidelines)
2) frequent severe exacerbations: two or more bursts of systemic CS (>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
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
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
6) is using long-term oxygen therapy at sea level (exclusion criterium for treatment at high-altitude at the Dutch Asthma Centre Davos)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53835.018.15 |
| OMON | NL-OMON23233 |