Clinical Trials List
Protocol NumberD6830C00003
Active
2024-10-31 - 2026-12-31
Phase II
Recruiting8
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)
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Trial Applicant
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Sponsor
AZ
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 莊政皓 Division of Thoracic Medicine
- Ming-Ju Tsai Division of Thoracic Medicine
- 鄭孟軒 Division of Thoracic Medicine
- 陳家閔 Division of Thoracic Medicine
- Hung-Ling Huang Division of Thoracic Medicine
- 鄭至宏 Division of Thoracic Medicine
- Wei-An Chang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 阮聖元 Division of General Internal Medicine
- 廖庭淯 無
- CHUN-TA HUANG 無
- 黃俊凱 Division of General Internal Medicine
- 鐘桂彬 Division of Others
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 江振源 Division of Thoracic Medicine
- Yu-Tien Tzeng Division of Thoracic Medicine
- Shian-Jiun Lin Division of Thoracic Medicine
- Kuan-Jen Bai Division of Thoracic Medicine
- 石智元 Division of Thoracic Medicine
- Chih-Hsin Lee Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Pai-Chien Chou
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Asthma
Objectives
To evaluate the effect of AZD8630 as compared to
placebo on time to first CompEx Asthma event in
patients with uncontrolled asthma at risk of
exacerbations
Test Drug
dry powder inhaler
Active Ingredient
AZD8630
Dosage Form
430
Dosage
0.4 mg, 2 mg, 8 mg
Endpoints
Dose selection using a Hochberg procedure to find the
optimal efficacious dose with a 2-sided P-value ≤ 0.10
at 12 weeks
Population: FAS
Endpoint: time to first CompEx Asthma event
Population-level summary measure: HR
Strategy for intercurrent events: Primary: while on
optimal efficacious dose with a 2-sided P-value ≤ 0.10
at 12 weeks
Population: FAS
Endpoint: time to first CompEx Asthma event
Population-level summary measure: HR
Strategy for intercurrent events: Primary: while on
Inclution Criteria
Patients are eligible to be included in the study only if all of the following criteria apply:
Age
1. Patient must be 18 to 80 years of age inclusive, at the time of signing the ICF
Type of Participant and Disease Characteristics
2. Documented physician diagnosis of asthma for at least 12 months, as evidenced by any of
the following:
(a) Post-BD reversibility of FEV1 > 12% and > 200 mL within 5 years prior to Visit 1, or
(b) PEF average daily variability > 10% over a 2-week period within 5 years prior to
Visit 1, or
(c) Variability of FEV1 > 12% and 200 mL between any 2 clinical visits within 5 years
prior to Visit 1, or
(d) Positive bronchial challenge test within 5 years prior to Visit 1. A positive test is
defined as a fall in FEV1 from pre-challenge of ≥ 20% with standard doses of
methacholine or ≥ 15% with standardised hyperventilation, hypertonic saline, or
mannitol challenge, or
(e) Positive exercise challenge test within 5 years prior to Visit 1. A positive test is
defined as a fall in FEV1 of > 10% and > 200 mL from pre-challenge, or
(f) Significant increase in lung function after 4 weeks of anti-inflammatory treatment
with ICS-containing treatment (GINA 2023) within 5 years prior to Visit 1, defined as
an increase in FEV1 > 12% and 200 mL (or PEF by >20%)
If documentation is not available to support any of these diagnostic criteria, and if in the
opinion of the Investigator the clinical diagnosis of asthma is still considered likely, the
investigation and confirmation of an average daily variability of PEF > 10% over a
2-week period or evidence of post-BD reversibility of FEV1 > 12% and > 200 mL or
≥20% improvement of PEF in 15 minutes after giving 2 puffs of albuterol/salbutamol can
also be considered as confirmatory of the diagnosis of asthma, if undertaken during the
period between Visit 1 and Visit 2.
3. Treated with medium- or high-dose ICS (as per GINA 2023) in combination with LABA
(GINA Step 4 or 5 therapy); the dose of ICS must be stable for at least 30 days prior to
Visit 1. The ICS can be contained within an ICS-LABA fixed-dose combination product.
Note: Treatment with additional asthma controller therapies (eg, LAMA) at a stable dose
≥ 30 days prior to Visit 1 is allowed.
4. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 at both Visit 1 and
Visit 2.
5. Pre-BD FEV1 ≥ 40% at both Visit 1 and Visit 2.
6. A pre-BD/pre-study intervention dose FEV1 at Visit 2 that has not increased by ≥ 400 mL
from the pre-BD FEV1 recorded at Visit 1.
7. Patient has documented evidence of any of the following:
(a) A history of 1 severe exacerbation within the last 12 months and either:
(i) FeNO ≥ 25 ppb at the screening and randomisation visits (Visits 1 and 2)
(ii) Eosinophil count ≥ 150 cells/µL, recorded at any point in the 12 months up to
and including the Screening Visit (local testing can be carried out to confirm
eligibility if eosinophil count not available in medical records within the last
12 months).
(b) A history of ≥ 2 severe exacerbations within 12 months of Visit 1.
A severe exacerbation is defined as an episode of symptoms of asthma worsening that
results in at least one of the following: OCS use for 3 consecutive days, inpatient
(≥ 24 hours) hospitalisation for asthma or emergency room or equivalent visit for asthma
that results in systemic CS use.
8. At least 80% (approximate) compliance with usual asthma background medication during
the run-in period based on the daily asthma ePROs i.e. minimum of 11 days. Note: 11 days
approximates to 80%.
Age
1. Patient must be 18 to 80 years of age inclusive, at the time of signing the ICF
Type of Participant and Disease Characteristics
2. Documented physician diagnosis of asthma for at least 12 months, as evidenced by any of
the following:
(a) Post-BD reversibility of FEV1 > 12% and > 200 mL within 5 years prior to Visit 1, or
(b) PEF average daily variability > 10% over a 2-week period within 5 years prior to
Visit 1, or
(c) Variability of FEV1 > 12% and 200 mL between any 2 clinical visits within 5 years
prior to Visit 1, or
(d) Positive bronchial challenge test within 5 years prior to Visit 1. A positive test is
defined as a fall in FEV1 from pre-challenge of ≥ 20% with standard doses of
methacholine or ≥ 15% with standardised hyperventilation, hypertonic saline, or
mannitol challenge, or
(e) Positive exercise challenge test within 5 years prior to Visit 1. A positive test is
defined as a fall in FEV1 of > 10% and > 200 mL from pre-challenge, or
(f) Significant increase in lung function after 4 weeks of anti-inflammatory treatment
with ICS-containing treatment (GINA 2023) within 5 years prior to Visit 1, defined as
an increase in FEV1 > 12% and 200 mL (or PEF by >20%)
If documentation is not available to support any of these diagnostic criteria, and if in the
opinion of the Investigator the clinical diagnosis of asthma is still considered likely, the
investigation and confirmation of an average daily variability of PEF > 10% over a
2-week period or evidence of post-BD reversibility of FEV1 > 12% and > 200 mL or
≥20% improvement of PEF in 15 minutes after giving 2 puffs of albuterol/salbutamol can
also be considered as confirmatory of the diagnosis of asthma, if undertaken during the
period between Visit 1 and Visit 2.
3. Treated with medium- or high-dose ICS (as per GINA 2023) in combination with LABA
(GINA Step 4 or 5 therapy); the dose of ICS must be stable for at least 30 days prior to
Visit 1. The ICS can be contained within an ICS-LABA fixed-dose combination product.
Note: Treatment with additional asthma controller therapies (eg, LAMA) at a stable dose
≥ 30 days prior to Visit 1 is allowed.
4. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 at both Visit 1 and
Visit 2.
5. Pre-BD FEV1 ≥ 40% at both Visit 1 and Visit 2.
6. A pre-BD/pre-study intervention dose FEV1 at Visit 2 that has not increased by ≥ 400 mL
from the pre-BD FEV1 recorded at Visit 1.
7. Patient has documented evidence of any of the following:
(a) A history of 1 severe exacerbation within the last 12 months and either:
(i) FeNO ≥ 25 ppb at the screening and randomisation visits (Visits 1 and 2)
(ii) Eosinophil count ≥ 150 cells/µL, recorded at any point in the 12 months up to
and including the Screening Visit (local testing can be carried out to confirm
eligibility if eosinophil count not available in medical records within the last
12 months).
(b) A history of ≥ 2 severe exacerbations within 12 months of Visit 1.
A severe exacerbation is defined as an episode of symptoms of asthma worsening that
results in at least one of the following: OCS use for 3 consecutive days, inpatient
(≥ 24 hours) hospitalisation for asthma or emergency room or equivalent visit for asthma
that results in systemic CS use.
8. At least 80% (approximate) compliance with usual asthma background medication during
the run-in period based on the daily asthma ePROs i.e. minimum of 11 days. Note: 11 days
approximates to 80%.
Exclusion Criteria
Patients are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Life-threatening asthma defined as a history of significant asthma episode(s) involving
intubation, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
2. Completed treatment for respiratory infection and/or asthma exacerbation with systemic
corticosteroids and/or antibiotics for > 3 days in the 4 weeks prior to Visit 1, or during the
screening / run-in period.
3. Clinically important pulmonary disease other than asthma; including but not limited to
those with co-existent chronic obstructive pulmonary disease.
4. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal,
neurological, musculoskeletal, infectious, endocrine, metabolic, haematological,
psychiatric, or major physical impairment 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. Investigation for active or latent TB, with
interferon gamma release assay (IGRA) and/or chest X-ray, should only be considered if
deemed clinically indicated by the Principal Investigator.
6. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C,
as defined by:
(a) Positive test for HBsAg
(b) Positive test for anti-HBc: Patients who test positive for anti-HBc antibody but
negative for HBsAg may be enrolled if their hepatitis B virus DNA test result is
negative
(c) Positive test for anti-hepatitis C antibody: Patients who test positive for antihepatitis C
antibody may be enrolled if their hepatitis C viral RNA test result is negative in the
absence of liver cirrhosis
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 (eg, multifocal premature ventricular
contractions, bigeminy, trigeminy, ventricular tachycardia).
Note: Patients with clinically significant sinus nodal disease/bradycardia or type 2
second- or third-degree atrioventricular block can be included if treated with a pacemaker.
10. Patients with recent myocardial infarction, unstable angina pectoris, stroke, or
percutaneous coronary intervention within 3 months of Visit 1 or coronary artery bypass
grafting within 6 months of Visit 1.
11. A helminth parasitic infection diagnosed within 24 weeks of Visit 1 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 before Visit 1 (including all forms of tobacco, e-cigarettes
[vaping], and other recreational drugs including marijuana).
13. Known history of drug or alcohol abuse within the 12 months prior to Visit 1, that in the
Investigator’s opinion would preclude participation in the study. The use of oral cannabis
is permitted.
14. Current diagnosis of cancer or unresectable cancer that has not been in complete remission
for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the
skin and cervical carcinoma-in-situ that have been treated and considered cured at the time
of enrolment are not exclusionary.
15. Any other clinically relevant abnormal findings on vital signs, physical examination, or
clinical laboratory testing including haematology, coagulation, clinical chemistry, or ECG
between Visit 1 and Visit 2, 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. Abnormal findings include, but are not limited to:
(a) ALT or AST > 2 × ULN
(b) TBL > 1.5 × ULN (unless due to Gilbert’s disease)
Medical Conditions
1. Life-threatening asthma defined as a history of significant asthma episode(s) involving
intubation, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
2. Completed treatment for respiratory infection and/or asthma exacerbation with systemic
corticosteroids and/or antibiotics for > 3 days in the 4 weeks prior to Visit 1, or during the
screening / run-in period.
3. Clinically important pulmonary disease other than asthma; including but not limited to
those with co-existent chronic obstructive pulmonary disease.
4. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal,
neurological, musculoskeletal, infectious, endocrine, metabolic, haematological,
psychiatric, or major physical impairment 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. Investigation for active or latent TB, with
interferon gamma release assay (IGRA) and/or chest X-ray, should only be considered if
deemed clinically indicated by the Principal Investigator.
6. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C,
as defined by:
(a) Positive test for HBsAg
(b) Positive test for anti-HBc: Patients who test positive for anti-HBc antibody but
negative for HBsAg may be enrolled if their hepatitis B virus DNA test result is
negative
(c) Positive test for anti-hepatitis C antibody: Patients who test positive for antihepatitis C
antibody may be enrolled if their hepatitis C viral RNA test result is negative in the
absence of liver cirrhosis
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 (eg, multifocal premature ventricular
contractions, bigeminy, trigeminy, ventricular tachycardia).
Note: Patients with clinically significant sinus nodal disease/bradycardia or type 2
second- or third-degree atrioventricular block can be included if treated with a pacemaker.
10. Patients with recent myocardial infarction, unstable angina pectoris, stroke, or
percutaneous coronary intervention within 3 months of Visit 1 or coronary artery bypass
grafting within 6 months of Visit 1.
11. A helminth parasitic infection diagnosed within 24 weeks of Visit 1 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 before Visit 1 (including all forms of tobacco, e-cigarettes
[vaping], and other recreational drugs including marijuana).
13. Known history of drug or alcohol abuse within the 12 months prior to Visit 1, that in the
Investigator’s opinion would preclude participation in the study. The use of oral cannabis
is permitted.
14. Current diagnosis of cancer or unresectable cancer that has not been in complete remission
for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the
skin and cervical carcinoma-in-situ that have been treated and considered cured at the time
of enrolment are not exclusionary.
15. Any other clinically relevant abnormal findings on vital signs, physical examination, or
clinical laboratory testing including haematology, coagulation, clinical chemistry, or ECG
between Visit 1 and Visit 2, 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. Abnormal findings include, but are not limited to:
(a) ALT or AST > 2 × ULN
(b) TBL > 1.5 × ULN (unless due to Gilbert’s disease)
The Estimated Number of Participants
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Taiwan
17 participants
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Global
516 participants
