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Monitoring of exhaled nitric oxide (FENO) to tailor the lowest effective dose of oral corticosteroids in severe asthma (MONOSA-Study).


- candidate number2924
- NTR NumberNTR1146
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-nov-2007
- Secondary IDsincomplete 
- Public TitleMonitoring of exhaled nitric oxide (FENO) to tailor the lowest effective dose of oral corticosteroids in severe asthma (MONOSA-Study).
- Scientific TitleMonitoring of exhaled nitric oxide (FENO) to tailor the lowest effective dose of oral corticosteroids in severe asthma (MONOSA-Study).
- ACRONYMMONOSA
- hypothesis1. Daily home monitoring of exhaled nitric oxide (FENO) in patients with severe asthma facilitate tapering of oral corticosteroids to the lowest possible dose, leading to a reduction of total corticosteroid consumption;
2. This can be achieved without a deleterious effect on asthma control and disease-associated quality of life.
- Healt Condition(s) or Problem(s) studiedSevere asthma
- Inclusion criteria1. 18-65 years;
2. Pulmonologysts’ diagnosis of severe asthma;
3. Daily or alternate day oral corticosteroid therapy for at least 1 month before entering into the study;
4. Maintenance high dose inhaled corticosteroids (at least 1600 mcg/day beclomethasone equivalent) and long- and short acting bronchodilators for more than one year.
- Exclusion criteria1. Patient not able to perform adequate measurements of FENO at home;
2. Patient without mobile phone or internet access.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2007
- planned closingdate1-mrt-2009
- Target number of participants100
- InterventionsPatients are randomised 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.
- Primary outcome1. Cumulative dose of OCS;
2. symptoms (ACQ);
3. quality of life (AQLQ);
4. patient's health state (VAS).
- Secondary outcome1. EQ-5D;
2. SF-12;
3. lung function;
4. exacerbations;
5. emergency visits;
6. hospitalisations;
7. steroid side effects.
- TimepointsN/A
- Trial web sitehttp://www.astma.nu/monosa/
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD, PhD Elisabeth H.D. Bel
- CONTACT for SCIENTIFIC QUERIES Simone Hashimoto
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, Haga Teaching Hospital, Department of Pulmonology, Medisch Spectrum Twente, Leiden University Medical Center (LUMC), Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Aerocrine AB
- PublicationsN/A
- Brief summaryPatients with steroid dependent asthma have continued morbidity from both their disease and the systemic steroid (OCS) that they are using. Specialists try to adjust their OCS dose based on symptoms and signs, without the use of a specific marker reflecting the activity of the underlying inflammatory process. Our question is whether the exhaled nitric oxide (FENO) can help in tapering OCS in patients with severe asthma while maintaining asthma control, in order to decrease the incidence of serious side effects and to improve quality of life (QoL).
Measurements of the fraction of exhaled nitric oxide 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. We postulate that a FENO-based strategy for steroid-dose adjustment could help to reduce the cumulative steroid dose and improve quality of life in patients with severe asthma.
Therefore 100 adults with steroid dependent asthma will be randomised in 2 strategies: dose adjustments of 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.
- Main changes (audit trail)
- RECORD28-nov-2007 - 9-feb-2010


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