| Primary objective: To reduce the consumption of oral corticosteroids in patients with severe asthma while maintaining asthma control, in order to decrease the incidence of serious side effects and improve quality of life.Research question1. Does 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. Can this be achieved without a deleterious effect on asthma control and disease-associated quality of life? ObjectiveTo reduce the consumption of oral corticosteroids (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).Research questions1. 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 population100 Adults (18-65 yr) with severe asthma from 3 hospitals. Daily or alternate day OCS for 1 months or more.Study design/intervention A prospective, randomised, parallel, multicenter trial. Randomisation 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.Outcome measures Primary: cumulative dose of OCS, symptoms (ACQ), quality of life (AQLQ), patient s health state (VAS). Secondary: EQ-5D, SF-12, lung function, exacerbations, emergency visits, hospitalisations, steroid side effectsPower/data analysis50 Patients per arm suffice to detect a difference of 0.39 and 0.34 points change in ACQ and AQLQ between the two arms, respectively (a=0.05 two-sided, ß=0.20 one-sided). Economic evaluation Short term quality of life and health care consumption will be explored, but will not be combined in a formal economic evaluation |
