To reduce the consumption of oral corticosteroids (OCS) in patients with severe asthma while maintaining asthma control, in order to decrease the incidence of long-term steroid-induced side effects and to improve quality of life (QoL). The specific…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cumulative dose of oral corticosteroids, symptoms (ACQ), quality of life
(AQLQ), patient's health state (VAS).
Secondary outcome
EQ-5D, SF-12, lung function, exacerbations, emergency visits, hospitalisations,
steroid side effects
Background summary
The goal of therapy in patients with severe asthma is to achieve the best
possible result on symptoms and lung function, and the least adverse effects
from medication. Measurements of the fraction of exhaled nitric oxide (FENO)
constitute a non-invasive marker of airway inflammation that has been
successfully used to adjust the dose of inhaled corticosteroids in
mild-to-moderate asthma in adults. A pilot study performed at the Leiden
University Medical Center in severe asthmatic adults using 10-130 mg oral
prednisone daily, showed that FENO could be used to safely reduce and
ultimately discontinue OCS This suggests that FENO is an appropriate tool that
can be used to tailor the lowest effective dose of OCS in patients with severe
asthma while maintaining asthma control and improving quality of life.
Study objective
To reduce the consumption of oral corticosteroids (OCS) in patients with severe
asthma while maintaining asthma control, in order to decrease the incidence of
long-term steroid-induced side effects and to improve quality of life (QoL).
The specific research questions are:
1. Does monitoring of exhaled nitric oxide (FENO) in severe asthma facilitate
tapering of OCS to the lowest effective dose, leading to a reduction of
corticosteroid consumption?
2. Can this be achieved without worsening of asthma control or asthma-related
QoL (AQLQ)?
Study design
A prospective, randomised, parallel, multicenter trial. Randomisation in 2
strategies: dose adjustments of oral corticosteroids (OCS) according to usual
care on a monthly basis or guided by FENO (FENO strategy). All patients record
symptoms and lung function daily, and complete asthma control questionnaires
(ACQ) weekly. Patients in the FENO strategy group also measure FENO daily at
home. Data are transferred via an asthma monitoring service using SMS messages
or Internet. Patients in the FENO group receive instructions to adjust the dose
of OCS electronically on a weekly basis. Both groups are followed for 6 months.
Intervention
see Study design
Study burden and risks
The burden for the patient is:
Daily monitoring of symptoms, medication use and measurement of lung function
by a handeheld electronic spirometer (10 minutes). Weekly completion of asthma
control questionnaire (10 minute). Transfer of data via SMS or internet to a
central computer.
2. Monthly visits to the pulmonologist (15 minutes appointment)
3. three-monthly completion of 3 questionnaires (15 minutes)
The health risk for the patient by this intervention is not increased, it is
probably decreased.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
- 18-65 years
- pulmonologist's diagnosis of severe asthma
- daily or alternate day oral corticosteroid therapy for at least 1 month before entering into the study
- maintenance high dose inhaled corticosteroids (at least 1600 mcg/day beclomethasone equivalent) and long- and short acting bronchodilators for more than one year
Exclusion criteria
- The patient is not able to perform adequate measurements of FENO at home
- The patient has no mobile phone or internet access
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 |
|---|---|
| CCMO | NL14613.058.06 |