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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled asthma | Experimental |
| |
| Uncontrolled asthma with additional OCS | Experimental |
| |
| Uncontrolled asthma without additional OCS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LABA | Drug | long-acting beta-agonist treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum periostin levels | up to 95 days |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma quality of life questionnaire for adults and adolescents aged 12 years and older (AQLQ12+) | up to 95 days | |
| IL-13 related biomarker levels | up to 95 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast | BT9 7AB | United Kingdom | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30940770 | Derived | Busby J, Holweg CTJ, Chai A, Bradding P, Cai F, Chaudhuri R, Mansur AH, Lordan JL, Matthews JG, Menzies-Gow A, Niven R, Staton T, Heaney LG. Change in type-2 biomarkers and related cytokines with prednisolone in uncontrolled severe oral corticosteroid dependent asthmatics: an interventional open-label study. Thorax. 2019 Aug;74(8):806-809. doi: 10.1136/thoraxjnl-2018-212709. Epub 2019 Apr 2. |
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| corticosteroids | Drug | chronic treatment with oral corticosteroids, high dose inhaled corticosteroids |
|
| prednisolone | Drug | additional 0.5 mg/kg orally for 7 days |
|
| Lung function: Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) |
| up to 95 days |
| Safety: Incidence of adverse events | up to 95 days |
| Patient reported outcomes: Asthma Control Questionnaire (ACQ-7) | up to 95 days |
| Birmingham |
| B9 5SS |
| United Kingdom |
| Glasgow | G12 0XH | United Kingdom |
| Glasgow | G21 3UW | United Kingdom |
| Hampshire | SO16 6YD | United Kingdom |
| Leicester | LE3 9QP | United Kingdom |
| London | EC1A 7BE | United Kingdom |
| London | SW3 6NP | United Kingdom |
| Manchester | M23 9LT | United Kingdom |
| Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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