Step 1
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LABA/low-dose ICS (FP 200 μg or equivalent)
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Step 2
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LABA/moderate-dose ICS (500 μg FP equivalent)
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Step 3
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LABA/high-dose ICS (1000 μg FP equivalent)
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Step 4
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Add Tiotropium
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Step 5*
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Add regular oral steroids (starting dose 5–10 mg per day increasing in 5 mg increments)
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- * It is recognised that on some occasions patients may require higher doses of systemic steroids beyond 20 mg prednisolone per day; as with all treatment steps, particular attention should be paid to adherence with prednisolone, but if required prednisolone can be increased in further 5-mg increments
- The therapeutic adjustments are designed to reflect clinical practice and to be pragmatic and allow accommodation of currently used combination inhaler therapies in this population; because of this, ICS will be adjusted in line with the patient’s prescribed LABA/ICS inhaler device. This will mean in some situations that LABA is adjusted along with ICS which would reflect usual clinical practice
- If patient is on theophylline, leukotriene receptor antagonist, at baseline, these are not adjusted during study; they are not added during the study
- If patient has an Asthma Control Questionnaire (ACQ)7 > 1.5 and corticosteroid is not increased, tiotropium should be added if no contraindications if patient is not already on Long-Acting Muscarinic Antagonist (LAMA) therapy or nebulised short-acting anti-muscarinic therapy
- If on inhaled steroid monotherapy (nebulised or inhaled) in addition to ICA/LABA combination therapy, the inhaled steroid monotherapy will be withdrawn initially
- If a patient is on oral steroids and reduces to 5 mg per day, they should be advised to omit their prednisolone on the morning of their next study visit; at that visit, they should have a morning cortisol checked locally as part of routine clinical care: if cortisol within normal range of local laboratory reference value, steroids can be stopped completely if indicated by study algorithm; if cortisol is present but outside normal reference range of local laboratory, gradual oral steroid withdrawal in 1 mg increments is carried out; if cortisol is undetectable, prednisolone is maintained at 5 mg for study duration
- FP fluticasone propionate, ICS inhaled corticosteroid, LABA long-acting beta agonist