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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19976

Enrollment

100

Registered

2007-11-28

Start date

2007-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Severe asthma

Interventions

Patients 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 l

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. Patient not able to perform adequate measurements of FENO at home; 2. Patient without mobile phone or internet access.

Design outcomes

Primary

Measure	Time frame
1. Cumulative dose of OCS; 2. symptoms (ACQ); 3. quality of life (AQLQ); 4. patient's health state (VAS).	—

Secondary

Measure	Time frame
1. EQ-5D; 2. SF-12; 3. lung function; 4. exacerbations; 5. emergency visits; 6. hospitalisations; 7. steroid side effects.	—

Contacts

Public ContactElisabeth H.D. Bel

Academic Medical Center, Amsterdam University,

e.h.bel@amc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)