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An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | All included patients underwent dose reduction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change to dose of patient's regular medication | Drug | Dose reduction of the drug each patient was already taking |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responsiveness to metacholine bronchial challenge | PD(20) if positive test | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ACQ score | asthma control questionnaire | 8 weeks |
| miniAQLQ score | asthma quality of life score | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lungemedicinsk Forskningsenhed | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Pulmonary function tests | FEV1, FVC, reversibility to beta agonist | 8 weeks |
| FeNO | fraction of exhaled nitric oxide | 8 weeks |
| Sputum cell differentials | sputum neutrophil and eosinophil counts | 8 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |