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Assessing the safety and effectiveness of AZD8630 for uncontrolled asthma

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)

PHASE2 · AstraZeneca · NCT06529419

This study is testing a new inhaled medication called AZD8630 to see if it can help adults with uncontrolled asthma feel better and reduce their risk of asthma attacks.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment516 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAstraZeneca (industry)
Locations231 sites (Mesa, Arizona and 230 other locations)
Trial IDNCT06529419 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of AZD8630, an inhaled medication, in adults with uncontrolled asthma who are at risk of exacerbations. It is a Phase II, randomized, placebo-controlled, double-blind study that will administer multiple dose levels of AZD8630 via a dry powder inhaler. The study will involve approximately 516 patients across 220 centers in 20-25 countries, with a treatment duration of up to 52 weeks for participants. The goal is to determine the optimal dose that provides the best balance of efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a documented diagnosis of asthma, experiencing uncontrolled symptoms and a history of exacerbations.

Not a fit: Patients with a history of life-threatening asthma or recent respiratory infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with uncontrolled asthma, potentially reducing the frequency of exacerbations.

How similar studies have performed: Previous studies of similar inhaled medications have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Principal inclusion criteria (abbreviated):

1. Patient must be 18 to 80 years of age inclusive
2. Documented physician diagnosis of asthma for at least 12 months, with objective evidence of asthma (spirometric, bronchial challenge, exercise challenge or therapeutic response) within the last 5 years

4. Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5)

5. Pre-BD FEV1 ≥ 40%

7. A history of asthma exacerbations within the last 12 months

8. \& 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry.

10. BMI within the range 18-37 kg/m2 (inclusive)

11. Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception.

12. Male patients and their female partners of childbearing potential must agree to use highly effective contraception.

13. Capable of giving signed informed consent.

Principal exclusion criteria (abbreviated):

1. History of life-threatening asthma
2. Recently completed treatment for respiratory infection and/or asthma exacerbation
3. Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease.
4. Any disorder that is not stable in the opinion of the Investigator and could:

   1. Affect the safety of the patient throughout the study
   2. Influence the findings of the study or their interpretation
   3. Impede the patient's ability to complete the entire duration of study
5. Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.
6. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C
7. Patients with history of HIV infection or who test positive for HIV.
8. Congenital long QT syndrome or prolonged QTcF \> 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication.
9. Current untreated or uncontrolled arrhythmia.
10. Patients with recent myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention or coronary artery bypass grafting.
11. A helminth parasitic infection diagnosed that has not been treated, or has not responded to SoC therapy.
12. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months ago.
13. Known history of drug or alcohol abuse within 12 months, that in the Investigator's opinion would preclude participation in the study.
14. Current diagnosis of cancer or unresectable cancer that has not been in complete remission for at least 5 years.
15. Any other clinically relevant abnormal findings that in the opinion of the Investigator or medical monitor might compromise the safety of the patient in the study or interfere with evaluation of the study intervention.
16. Treatment with marketed or investigational biologics within 4 months or a minimum of 5 half-lives.
17. Treatment with Systemic steroids within 4 weeks.
18. Chronic oral or systemic CS use for asthma or for any other indication (with the exception of stable replacement therapy in adrenal insufficiency).

Where this trial is running

Mesa, Arizona and 230 other locations

+181 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Asthma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.