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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

NCT06529419

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: AZD8630, Placebo, Inhaler

Countries: United States, Argentina, Belgium, Chile, China, Czechia, Denmark, France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).

Locations (196)

Mesa, Arizona, United States
Huntington Beach, California, United States
La Mesa, California, United States
Laguna Niguel, California, United States
Lancaster, California, United States
Long Beach, California, United States
San Jose, California, United States
New Haven, Connecticut, United States
DeBary, Florida, United States
Jacksonville, Florida, United States
Jensen Beach, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Tampa, Florida, United States
Lilburn, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Winfield, Illinois, United States
Ames, Iowa, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Methuen, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Riverdale, New Jersey, United States
Middletown, New York, United States
Greenville, North Carolina, United States
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