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SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma
- Source :
- Respiratory Research, Respiratory Research, Vol 21, Iss 1, Pp 1-10 (2020)
- Publication Year :
- 2020
- Publisher :
- Springer Science and Business Media LLC, 2020.
-
Abstract
- Background Many patients with severe asthma continue to experience asthma symptoms and exacerbations despite standard-of-care treatment. A substantial proportion of these patients require long-term treatment with oral corticosteroids (OCS), often at high doses, which are associated with considerable multiorgan adverse effects, including metabolic disorders, osteoporosis and adrenal insufficiency. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. In the PATHWAY phase 2b study (NCT02054130), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma. Several ongoing phase 3 trials (SOURCE, NCT03406078; NAVIGATOR, NCT03347279; DESTINATION, NCT03706079) are assessing the efficacy and safety of tezepelumab in patients with severe, uncontrolled asthma. Here, we describe the design and objectives of SOURCE, a phase 3 OCS-sparing study. Methods SOURCE is an ongoing phase 3, multicentre, randomized, double-blind, placebo-controlled study to evaluate the effect of tezepelumab 210 mg administered subcutaneously every 4 weeks on OCS dose reduction in adults with OCS-dependent asthma. The study comprises a 2-week screening and enrolment period, followed by an OCS optimization phase of up to 8 weeks and a 48-week treatment period, which consists of a 4-week induction phase, followed by a 36-week OCS reduction phase and an 8-week maintenance phase. The primary objective is to assess the effect of tezepelumab compared with placebo in reducing the prescribed OCS maintenance dose. The key secondary objective is to assess the effect of tezepelumab on asthma exacerbation rates. Other secondary objectives include the proportion of patients with a reduction in OCS dose (100% or 50% reduction or those receiving Conclusions SOURCE is evaluating the OCS-sparing potential of tezepelumab in patients with OCS-dependent asthma. SOURCE also aims to demonstrate that treatment with tezepelumab in patients with severe asthma is associated with reductions in exacerbation rates and improvements in lung function, asthma control and health-related quality of life, while reducing OCS dose. Trial registration NCT03406078 (ClinicalTrials.gov). Registered 23 January 2018. https://clinicaltrials.gov/ct2/show/NCT03406078
- Subjects :
- Adult
Male
Tezepelumab
medicine.medical_specialty
Adolescent
Exacerbation
medicine.drug_class
Injections, Subcutaneous
Administration, Oral
030204 cardiovascular system & hematology
Antibodies, Monoclonal, Humanized
Placebo
Young Adult
Study Protocol
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Quality of life
Adrenal Cortex Hormones
Asthma control
Internal medicine
Oral corticosteroids
medicine
Adrenal insufficiency
Humans
030212 general & internal medicine
Adverse effect
SOURCE
Aged
Asthma
lcsh:RC705-779
Aged, 80 and over
Maintenance dose
business.industry
lcsh:Diseases of the respiratory system
Middle Aged
Steroid-sparing
medicine.disease
Treatment Outcome
Alarmin
TSLP
Corticosteroid
Female
Epithelial
business
Subjects
Details
- ISSN :
- 1465993X
- Volume :
- 21
- Database :
- OpenAIRE
- Journal :
- Respiratory Research
- Accession number :
- edsair.doi.dedup.....11a03f171e79c7d576b845ffbc819916
- Full Text :
- https://doi.org/10.1186/s12931-020-01503-z