NL-OMON51184撤回3 期
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) - KALOS
Astra Zeneca0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 28
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
- 12 至 99（—）
入选标准
- •(1.) Female or male subjects between 12-80 years inclusive, at the time of
- •signing the ICF. (2.) Participants who have a documented history of
- •physician-diagnosed asthma *1 year prior to Visit 1, according to GINA
- •guidelines [GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be
- •provided for adolescent participants (12 to <18 years of age) to ensure
- •consistent evaluation and follow-up of treatment in those participants. (3.)
- •Participants who have been regularly using a stable daily ICS/LABA regimen
- •(including a stable ICS dose), for at least 4 weeks prior to Visit 1. (4.) Have
- •a documented history of at least one asthma exacerbation requiring use of
- •systemic corticosteroids (oral or IV) for at least 3 days AND an associated
- •physician visit, hospitalization, or ER visit due to asthma (within 3 days of
- •the corticosteroid use) in the 12 months prior to Visit 1. (5.) ACQ-7 total
- •score *1.5 at Visits 1, 3, and 5 (pre-randomization). (6.) A pre-bronchodilator
- •FEV1 <80% predicted normal value at Visits 1, 2, 3, 4, and 5
- •(pre-randomization) for participants *18 years of age OR a pre-bronchodilator
- •FEV1 <90% predicted normal value at Visits 1, 2, 3, 4, and 5
- •(pre-randomization) for participants 12 to <18 years of age. (7.) Documented
- •reversibility to albuterol, which is defined as a post-albuterol increase in
- •FEV1 of *12% and *200 mL for participants *18 years of age OR a post-albuterol
- •increase of FEV1 of *12% for participants 12 to <18 years of age at Visit 2, or
- •at Visit 3 if repeat testing necessary. (8.) Willing and, in the opinion of the
- •Investigator, able to adjust current asthma therapy, as required by the
- •protocol. (9.) Received no asthma medication other than run-in BFF MDI BID and
- •albuterol as needed during screening, except for allowed medications defined in
- •Table 8 and systemic corticosteroid or ICS for the treatment of an asthma
- •exacerbation (see Section 5.5.2 regarding Screening extension). (10.) No
- •respiratory infection within 4 weeks of randomization, or asthma exacerbation
- •treated with systemic corticosteroid and/or additional ICS treatment within 4
- •weeks of randomization.
排除标准
- •(1.) Life-threatening asthma defined as a history of significant asthma
- •episode(s) requiring intubation associated with hypercapnia, respiratory
- •arrest, hypoxic seizures, or asthma-related syncopal episode(s). (2.) Completed
- •treatment for respiratory infection or asthma exacerbation with systemic
- •corticosteroids within 4 weeks of Visit 1. (3.) Hospitalization for asthma
- •within 2 months of Visit 1. (4.) Historical or current evidence of a clinically
- •significant disease including, but not limited to: cardiovascular, hepatic,
- •renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary.
- •(5.) Narrow angle glaucoma not adequately treated and/or change in vision that
- •may be relevant, in the opinion of the Investigator, within 3 months of Visit
- •1. (6.) Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary
- •retention that, in the opinion of the Investigator, is clinically significant.
- •(7.) Unresectable cancer that has not been in complete remission for at least 5
- •years prior to Visit 1. (8.) Oral and IV corticosteroid use (any dose) within 4
- •weeks of Visit 1. (9.) Depot corticosteroid use for any reason within 12 months
- •of Visit 1. (10.) Use of LAMA as maintenance treatment, either alone or as part
- •of an inhaled combination therapy, within 12 months prior to Visit 1. (11.) Use
- •of oral beta2-agonist within 3 months of Visit 1. (12.) Any marketed (e.g.,
- •omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic
- •within 3 months or 5 half-lives of Visit 1 (13.) Regular use of a nebulizer or
- •a home nebulizer for receiving asthma medications. (14.) Use of any
- •immunomodulators or immunosuppressive medication within 3 months or 5
- •half-lives. (15.) Participants with a known hypersensitivity to beta2-agonists,
- •corticosteroids, anticholinergics, or any component of the MDI or pMDI. (16.)
- •Current smokers, former smokers with >10 pack-years history, or former smokers
- •who stopped smoking <6 months prior to Visit 1. (17.) Planned hospitalization
- •during the study. (18.) Previous or current randomization in any budesonide and
- •formoterol fumarate studies (PT009), budesonide, glycopyrronium, and formoterol
- •fumarate studies (PT010), or glycopyrronium studies (PT001). (19.) For women
- •only * currently pregnant (confirmed with positive pregnancy test),
- •breastfeeding, or planned pregnancy during the study or not using acceptable
- •contraception measures, as judged by the Investigator.
研究者
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