Asthma
Conditions
Brief summary
An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.
Detailed description
We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects. This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control. After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.
Interventions
DRUGChange to dose of patient's regular medication
Dose reduction of the drug each patient was already taking
Sponsors
Bispebjerg Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed asthma for at least 6 months * Fulfill ERS/ATS giudelines for severe asthma * Stable dose of ICS for at least 4 weeks * Able to carry out study procedures * Negative metacholine provocation test at screening * Negative reversibility to beta agonist at screening * FeNO under 50 ppb
Exclusion criteria
* Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months * FEV1 under 70% of predicted * Acute upper or lower airway infection requiring antibiotics in the last 4 weeks * Exacerbation of asthma requiring prednisolone in the last 6 months * Current smoking * Pregnancy or breastfeeding * Other clinically significant lung disease * Current participation in another interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responsiveness to metacholine bronchial challenge | 8 weeks | PD(20) if positive test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACQ score | 8 weeks | asthma control questionnaire |
| miniAQLQ score | 8 weeks | asthma quality of life score |
| Pulmonary function tests | 8 weeks | FEV1, FVC, reversibility to beta agonist |
| FeNO | 8 weeks | fraction of exhaled nitric oxide |
| Sputum cell differentials | 8 weeks | sputum neutrophil and eosinophil counts |
Countries
Denmark
Outcome results
None listed