NL-OMON53653招募中2 期
A Phase 2a, Randomised, Double-Blind, Placebo Controlled Study to Assess Efficacy and Safety of Atuliflapon Given Orally Once Daily for Twelve Weeks in Adults with Moderate-to-Severe Uncontrolled Asthma - FLASH
Astra Zeneca0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Part 1 and Part 2 protocol 5.1.2.
- •General Inclusion Criteria for Part 1 and Part 2
- •10. Capable of giving signed informed consent
- •11. Provision of signed and dated written Optional Genetic Research Information
- •consent prior to collection of samples for optional genetic research that
- •supports Genomic
- •Initiative.
- •12. Participant is willing and able to follow study procedures and restrictions.
- •13. Participant must be 18 to 80 years of age inclusive, at the time of signing
- •14. Body weight 50 - 120 kg and body mass index (BMI) 18 -35 kg/m2.
- •15. Documented physician-diagnosed asthma >= 12 months prior to Visit 1.
- •16. Able to perform acceptable lung function testing for FEV1 according to
- •ATS/ERS 2019
- •acceptability criteria.
- •17. Documented evidence of asthma as demonstrated by either:
- •* Post-BD reversibility of FEV1 >= 12% and >= 200 within 5 years prior to Visit
- •1, or at Visit 1, or
- •* PEF average daily variability > 10% over a 2-week period within 5 years prior
- •to Visit 1, or
- •* Variability of FEV1 > 12% and 200 mL between any two clinical visits within 5
- •years prior to Visit 1, or
- •* Positive methacholine challenge test within the 5 years prior to Visit 1. A
- •positive result is defined as a PC20 <= 8 mg/mL.
- •18. Morning pre-BD FEV1 between >= 40% and <= 80% predicted at Visit 1.
- •19. Documented history of >= 1 severe asthma exacerbation within 3 years prior
- •to Visit 1.
- •20. Treated with low dose ICS-LABA or medium-high dose ICS (as per GINA 2021 ICS
- •equivalence table - Appendix C) alone or in combination with LABA at a stable
- •at least 3 months prior to Visit 1. (The ICS can be contained within an
- •ICS-LABA fixed
- •dose combination product).
- •* Treatment with additional asthma controller therapies (eg, LAMA) at a stable
- •>= 3 months prior to Visit 1 is allowed. (Treatment with LTRAs or 5-LO
- •inhibitors is not allowed.
- •21. An ACQ-6 score >= 1.5 at Visit 1 and at Visit 3.
- •22. Able and willing to comply with the requirements of the protocol including
- •read, write, be fluent in the translated language of all participant facing
- •questionnaires
- •used at site, and use electronic devices, eg, eCOA device and spirometry.
- •28. At least 80% compliance with usual asthma background medication during
- •run-in period
- •(from Visit 2 to Visit 3) based on the daily asthma ePROs.
- •29. Minimum 80% compliance with daily eCOA assessments.
- •24. For female participants, a negative serum pregnancy test.
- •25. Contraceptive use by female participants should be consistent with local
- •regulations
- •regarding the methods of contraception for those participating in clinical
- •studies. There
- •are no restrictions on male participants or their female partners.
排除标准
- •Protocol 5.2.1. 1. A severe asthma exacerbation within 8 weeks of
- •randomisation. 2. A positive nucleic acid test (eg RT-PCR) at Visit 1 or at
- •Visit 3 for SARS-CoV-2, the virus responsible for COVID-19. 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. 6. 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. * Impede the participant's ability to complete the
- •entire duration of study. 7. Any clinically significant cardiac disease: *
- •Acute coronary syndrome (acute myocardial infarction, unstable angina),
- •coronary intervention with percutaneous coronary intervention/coronary artery
- •bypass surgery or stroke within 6 months. * Heart failure NYHA II-IV. *
- •Untreated high degree atrioventricular-block (>= 3:1 conduction rate/Grade III
- •block)/ significant sinus node dysfunction/pause or therapy requiring
- •tachyarrhythmia. * History or family history of long QT-syndrome. * History of
- •QT prolongation associated with other medications that required discontinuation
- •of that medication. * Hypertrophic cardiomyopathy or clinically significant
- •valvular heart disease. * Stroke within 3 months of Visit 1. 8. History of
- •severe renal disease (CKD stage 4 or 5) or history of creatinine clearance < 30
- •mL/min × m2 calculated using Cockcroft-Gault equation. 9. Severe hepatic
- •impairment (Child-Pugh class C). 10. Previous hepatotoxicity related to
- •zileuton or LTRAs (eg montelukast) 11. Participants with a recent history of,
- •or who have a positive test for, infective hepatitis or unexplained jaundice,
- •or participants who have been treated for hepatitis B, hepatitis C, or HIV. For
- •the hepatitis B testing (HbsAg, anti-HBs, and anti-HBc), any of the following
- •would exclude the participant from the study: * Participants positive for
- •HbsAg. * Participants positive for anti-HBc. 12. Evidence of active or
- •untreated latent TB: * Positive IGRA, or repeated indeterminate IGRAs, no
- •evidence of active TB and untreated for LTBI, unable to be treated for, or
- •declines treatment of LTBI. * Participants newly diagnosed with LTBI at Visit 1
- •could be considered for rescreening if they complete a full course of treatment
- •for LTBI in accordance with recommended treatment guidelines prior to
- •rescreening. In this situation, repeat IGRA test is not required after
- •completion of treatment for LTBI. * Participants with an indeterminate IGRA
- •should underg
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