Asthma
Conditions
Interventions
This is a parallel-group treatment study with 4 arms that is patient and Investigator blinded. Patients will be randomly assigned in a 1:1:1:1 ratio to one of the 4 treatment arms.
- Experimental: AZ
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 or more) 5. Pre-BD FEV1 40% or more 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.
Exclusion criteria
Exclusion criteria: 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: a. Affect the safety of the patient throughout the study b. Influence the findings of the study or their interpretation c. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Outcome Measure Time to first CompEx Asthma event - Measure Description 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 - Time Frame 12 weeks | — |
Countries
Argentina, Belgium, Bulgaria, Chile, China, Czech Republic, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Mexico, Netherlands, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed