This interventional, open study will evaluate clinical data in relation to biomarkers in patients 12 to 75 years of age with severe oral corticosteroid (OCS) - dependent asthma. Patients with uncontrolled asthma will be offered an additional escalation of OCS at a dose of 0.5 mg/kg for 7 days. Patients enrolled in this study would be eligible to be enrolled in a future placebo-controlled intervention study designed to measure the steroid-sparing effect of lebrikizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
54
long-acting beta-agonist treatment
chronic treatment with oral corticosteroids, high dose inhaled corticosteroids
additional 0.5 mg/kg orally for 7 days
Unnamed facility
Belfast, United Kingdom
Unnamed facility
Birmingham, United Kingdom
Unnamed facility
Glasgow, United Kingdom
Unnamed facility
Glasgow, United Kingdom
Unnamed facility
Hampshire, United Kingdom
Unnamed facility
Leicester, United Kingdom
Unnamed facility
London, United Kingdom
Unnamed facility
London, United Kingdom
Unnamed facility
Manchester, United Kingdom
Unnamed facility
Newcastle upon Tyne, United Kingdom
...and 1 more locations
Serum periostin levels
Time frame: up to 95 days
Asthma quality of life questionnaire for adults and adolescents aged 12 years and older (AQLQ12+)
Time frame: up to 95 days
IL-13 related biomarker levels
Time frame: up to 95 days
Lung function: Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)
Time frame: up to 95 days
Safety: Incidence of adverse events
Time frame: up to 95 days
Patient reported outcomes: Asthma Control Questionnaire (ACQ-7)
Time frame: up to 95 days
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