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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 534
- Locations
- 1
- Primary Endpoint
- Time to first CompEx Asthma event
Study Overview
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 (ICS)/long-acting β2-agonist (LABA) and who have had ≥ 1 documented severe asthma exacerbation in the 12 months prior to enrolment.
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 asthma, who have had at least one severe exacerbation within the last 12 months, and whose asthma remains uncontrolled on medium to high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA). AZD8630 will be delivered via the inhaler which is designed to be a self-administered device for use by patients. The treatment period is 12 weeks, with an optional safety extension period of up to 52 weeks of total dosing. The study will evaluate the incidence of CompEx Asthma and other efficacy parameters, such as lung function and quality of life, and will provide adequate safety information in order to characterise the benefit-risk profile of AZD8630 treatment in patients with asthma.
This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Quadruple
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AZD8630 dose A
Inhaled AZD8630 administered at a dose A
Intervention: AZD8630 (Drug)
AZD8630 dose A
Inhaled AZD8630 administered at a dose A
Intervention: Inhaler (Device)
AZD8630 dose B
Inhaled AZD8630 administered at a dose B
Intervention: AZD8630 (Drug)
AZD8630 dose B
Inhaled AZD8630 administered at a dose B
Intervention: Inhaler (Device)
AZD8630 dose C
Inhaled AZD8630 administered at a dose C
Intervention: AZD8630 (Drug)
AZD8630 dose C
Inhaled AZD8630 administered at a dose C
Intervention: Inhaler (Device)
Placebo
Inhaled placebo
Intervention: Placebo (Drug)
Placebo
Inhaled placebo
Intervention: Inhaler (Device)
Outcomes
Primary Outcomes
Time to first CompEx Asthma event
Time Frame: 12 weeks
The CompEx Asthma is a composite endpoint for exacerbations that captures asthma-worsening episodes based on combination of diary events (worsening in daily PEF, asthma symptoms and rescue medication use) plus severe asthma exacerbation events. Diary events are defined by threshold and slope criteria using the following morning/evening diary variables: * PEF * Asthma symptom score (0 to 3) * Use of rescue medication
Secondary Outcomes
- Pre-BD FEV1(12 weeks)
- ACQ-6:(12 weeks)
- AQLQ12+(12 weeks)
- SGRQ(12 weeks)
- FeNO(12 weeks)