Table 5.

Treatment for symptom-based therapy adjustment (British Thoracic Society guidelines)

Step 1	LABA/low-dose ICS (FP 200 μg or equivalent)
Step 2	LABA/moderate-dose ICS (500 μg FP equivalent)
Step 3	LABA/high-dose ICS (1000 μg FP equivalent)
Step 4	Add Tiotropium
Step 5*	Add regular oral steroids (starting dose 5–10 mg per day increasing in 5 mg increments)

* 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monotherapy (nebulised or inhaled) in addition to ICA/LABA combination therapy, the inhaled steroid monotherapy will be withdrawn initially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