Clinical Trials List
2023-10-01 - 2026-12-31
Phase II
Recruiting10
ICD-10J45.20
Mild intermittent asthma, uncomplicated
ICD-10J45.30
Mild persistent asthma, uncomplicated
ICD-10J45.40
Moderate persistent asthma, uncomplicated
ICD-10J45.50
Severe persistent asthma, uncomplicated
ICD-10J45.909
Unspecified asthma, uncomplicated
ICD-9493.00
Extrinsic asthma without mention of status asthmaticus
A Phase 2a Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients with Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ming-Ju Tsai 無
- 鄭孟軒 無
- 陳家閔 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 廖培雅 無
- 歐偉凡 無
- 王俊隆 無
- 林雋 無
- Wei- Chang Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭書𡵓 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kang-Cheng Su 無
- 蕭逸函 無
- Jia-Yih Feng 無
- 蕭慈慧 無
- Wei-Zhi Chen 無
- 潘聖衛 無
- 沈曉津 無
- 余文光 無
- 黃仲儒 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Tien Tzeng 無
- Jer-Hwa Chang 無
- 石智元 無
- Shian-Jiun Lin 無
- 許金旺 無
- Kuan-Jen Bai 無
- 徐士昌 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 邱昱棋 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭書𡵓 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
either placebo or AZD4604 1.4 mg BID arms.
Endpoint: Time to first CompEx event.
Population-level summary measure: Hazard ratio, survival
estimates by Kaplan-Meier estimator.
Strategy of intercurrent events a:
Primary estimand: While on treatment – if an intercurrent event
occurs before first CompEx event, the participant will be
censored at the time of intercurrent event.
Supportive estimand: Treatment policy (reflects ITT principle) –
after intercurrent event, participants remain in the study so that
the endpoint could be studied until Week 12. Treatment policy
strategy used to estimate the efficacy of AZD4604 in “real
world” conditions.
Inclution Criteria
1 Participant must be 18 to 80 years of age inclusive, at the time of signing the informed
consent.
Type of Participant and Disease Characteristics
2 Participants treated with medium-high dose ICS (as per GINA 2024 ICS dose level table
in Appendix F) in combination with LABA at a stable dose for at least 28 days prior to
Visit 1 (the ICS can be contained within an ICS-LABA fixed dose combination
product).
Note: Participants being recruited from within the EU must be treated with high dose
ICS (per Appendix F) in combination with LABA at a stable dose for at least 28 days
prior to Visit 1; see Appendix H for EU-specific requirements.
− Treatment with additional asthma controller therapies (eg, LAMA, LTRA) at a
stable dose for ≥ 28 days prior to Visit 1 is allowed. Treatment with maintenance
systemic corticosteroids (oral or injectable) is not allowed (see Section 5.2,
Exclusion Criterion 12).
3 A documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1.
A severe asthma exacerbation is defined as a worsening of asthma that leads to any of the
following:
− Use of systemic corticosteroids for at least 3 consecutive days to treat symptoms
of asthma worsening (a single depo-injectable dose of corticosteroids will be
considered equivalent to a 3-day bolus/burst of systemic corticosteroids).
− An emergency room visit (defined as evaluation and treatment for < 24 hours in an
emergency department) due to asthma that required systemic corticosteroids (as
per the above).
− An inpatient hospitalisation (defined as admission to an inpatient facility and/or
evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma.
Exclusion Criteria
1 A severe asthma exacerbation within 8 weeks of prior to randomisation. (For definition of
severe exacerbation see Section 5.1, Inclusion Criterion 3).
2 History of herpes zoster reactivation eg, shingles.
3 Participants with a significant COVID-19 illness within 6 months of enrolment:
− Participants with a diagnosis of COVID-19 pneumonia based on radiological
assessment.
− Participants with a diagnosis of COVID-19 requiring hospitalisation and/or
oxygen supplementation therapy.
4 Clinically important pulmonary disease other than asthma eg, active lung infection,
COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome
associated with obesity, lung cancer, history or planned lung lobectomy, alpha-1
anti-trypsin deficiency, primary ciliary dyskinesia, Churg-Strauss syndrome, allergic
bronchopulmonary aspergillosis and hyper-eosinophilic syndrome.
5 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:
− affect the safety of the participant throughout the study,
− influence the findings of the study or the interpretation, or
− impede the participant’s ability to complete the entire duration of study.
The Estimated Number of Participants
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Taiwan
13 participants
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Global
320 participants
