Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529419
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2b Randomised Double-Blind Placebo-Controlled Dose Range-Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults With Uncontrolled Asthma at Risk of Exacerbations LEVANTE
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Levante
Brief Summary:
A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations receiving medium -to -high dose inhaled corticosteroid ICSlong-acting β2-agonist LABA
Detailed Description:
This is a Phase II randomised placebo-controlled double-blind dose range-finding multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with uncontrolled asthma at risk of an exacerbation The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included The maximal treatment period is up to 52 weeks
This study will be conducted in approximately 220 centres in 20-25 countries Approximately 516 patients will be randomised globally
This study will be conducted in approximately 220 centres in 20-25 countries Approximately 516 patients will be randomised globally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None