AZD8630 for Uncontrolled Asthma
(Levante Trial)
Recruiting in Palo Alto (17 mi)
+204 other locations
Overseen byNjira Lugogo
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AstraZeneca
Must be taking: Inhaled corticosteroids, Long-acting β2-agonists
Must not be taking: Systemic steroids, Biologics
Disqualifiers: COPD, HIV, Cancer, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires that you are compliant with your asthma background medication. If you are taking systemic steroids or certain biologics, you may need to stop them before joining the trial.
What data supports the effectiveness of the drug AZD8630 for uncontrolled asthma?
How is the drug AZD8630 different from other asthma treatments?
Eligibility Criteria
Adults with uncontrolled asthma who are still having issues despite using medium to high doses of inhaled steroids and long-acting inhalers. They must have had at least one severe asthma attack in the past year.Inclusion Criteria
I am between 18 and 80 years old.
I have been diagnosed with asthma for over a year.
Pre-BD FEV1 ≥ 40% at both Visit 1 and Visit 2
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Exclusion Criteria
My recent health checks showed some abnormal results.
I have a significant lung condition that is not asthma.
I have a history of hepatitis B, C, or HIV.
See 10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive inhaled AZD8630 or placebo once daily for 12 weeks
12 weeks
Weekly visits for monitoring and assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Optional Safety Extension
Participants may continue treatment for up to 52 weeks in an optional safety extension study
52 weeks
Treatment Details
Interventions
- AZD8630 (Corticosteroid)
Trial OverviewThe trial is testing different doses of a new drug called AZD8630, given through an inhaler, to see if it's effective and safe for people whose asthma isn't well-controlled by their current medications.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD8630 dose CExperimental Treatment2 Interventions
Inhaled AZD8630 administered at a dose C
Group II: AZD8630 dose BExperimental Treatment2 Interventions
Inhaled AZD8630 administered at a dose B
Group III: AZD8630 dose AExperimental Treatment2 Interventions
Inhaled AZD8630 administered at a dose A
Group IV: PlaceboPlacebo Group2 Interventions
Inhaled placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteMission Viejo, CA
Research SiteBoston, MA
Research SiteAnn Arbor, MI
Research SiteDetroit, MI
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor
References
Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. [2021]Patients with severe, uncontrolled asthma experience frequent exacerbations and hospitalization, leading to poor health-related quality of life. In the phase 2b PATHWAY study (NCT02054130), tezepelumab reduced exacerbations by up to 71% and improved lung function, asthma control, and health-related quality of life vs placebo.
Real-world evidence: Patient views on asthma in respiratory specialist clinics in America. [2021]Label="BACKGROUND">Approximately 30% to 50% of patients with moderate/severe asthma have inadequately controlled disease despite adherence to inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy. Data on prevalence and burden of uncontrolled asthma in specialty settings are lacking.
The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. [2022]Patients with severe persistent asthma who are inadequately controlled despite treatment according to current asthma management guidelines have a significant unmet medical need. Such patients are at high risk of serious exacerbations and asthma-related mortality.
An evidence-based, point-of-care tool to guide completion of asthma action plans in practice. [2018]Asthma action plans (AAPs) reduce healthcare utilisation, improve quality of life and are recommended across guidelines. However, fewer than 25% of patients receive an AAP, partly due to prescribers' inability to complete "yellow zone" instructions (how to intensify therapy for acute loss of control). We sought to review best evidence to develop a practical, evidence-based tool to facilitate yellow zone guidance in adults.We reviewed recent asthma guidelines and adult studies addressing acute loss of asthma control (January 2010 to March 2016). We developed evidence-based rules for yellow zone therapy and operational guidelines to maximise adherence and minimise errors.We reviewed three guidelines and 11 manuscripts (2486 abstracts screened). Recommendations were comparable but some areas lacked guidance. For 15/43 asthma regimens, the commonly recommended four- to five-fold yellow zone inhaled corticosteroid dose increase was problematic due to regulatory dose limits. We identified evidence-based alternatives for 8/15 regimens. Operational guidance included increasing to a maximum of four inhalations while maintaining baseline inhaler frequency and device in the yellow zone.We developed a practical implementation tool to facilitate AAP delivery at the point of care, addressing existing gaps and uncertainties. Our tool should be implemented as part of a multifaceted approach to augment AAP usage.
In severe, uncontrolled asthma, tezepelumab reduced exacerbations over 1 y regardless of type 2 inflammation level. [2023]Label="SOURCE CITATION" NlmCategory="UNASSIGNED">Corren J, Menzies-Gow A, Chupp G, et al. Efficacy of tezepelumab in severe, uncontrolled asthma: pooled analysis of the PATHWAY and NAVIGATOR clinical trials. Am J Respir Crit Care Med. 2023;208:13-24. 37015033.
Clinical pharmacokinetics of AZD3199, an inhaled ultra-long-acting β2-adrenoreceptor agonist (uLABA). [2018]The clinical pharmacokinetics of AZD3199, an ultra-long-acting β2-agonist, were investigated in healthy volunteers and patients with asthma or chronic obstructive pulmonary disease (COPD).
Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry. [2022]Refractory asthma represents a significant unmet clinical need. Data from a national online registry audited clinical outcome in 349 adults with refractory asthma from four UK specialist centres in the British Thoracic Society Difficult Asthma Network. At follow-up, lung function improved, with a reduction in important healthcare outcomes, specifically hospital admission, unscheduled healthcare visits and rescue courses of oral steroids. The most frequent therapeutic intervention was maintenance oral corticosteroids and most steroid sparing agents (apart from omalizumab) demonstrated minimal steroid sparing benefit. A significant unmet clinical need remains in this group, specifically a requirement for therapies which reduce systemic steroid exposure.
Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting β2-agonists in patients with atopic asthma. [2022]Label="OBJECTIVES" NlmCategory="OBJECTIVE">To evaluate the efficacy and safety of AZD1981, a potent, specific antagonist of the CRTh2 receptor, as add-on therapy to inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA), in patients with persistent asthma with an allergic component.
Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. [2022]Patients with severe asthma are often inadequately controlled on existing anti-asthma therapy, constituting an unmet clinical need.