JPRN-jRCT2031210576招募中3 期
A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants with Inadequately Controlled Asthma - VATHOS
Ageshi Yuji0 个研究点目标入组 138 人开始时间: 2022年1月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
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
- >= 12age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. 12 to 80 years of age, male and female, BMI less 40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
- •2. Participants who have a documented history of physician-diagnosed asthma 6 months or more 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 (age 12 years or more and below18 years) to ensure consistent evaluation and follow-up of treatment in those participants.
- •3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1.
- •4. ACQ-7 total score 1.5 or more at Visits 1 and 4.
- •5. Pre-bronchodilator/pre-dose FEV1 less than 90% predicted normal value at Visits 1, 2 and 3, and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).
- •6. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of 12% or more and 200 mL1 or more for participants 18 years or more of age OR a post-albuterol increase of FEV1 of 12% or more for participants 12 or more and below 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3.
- •7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit.
- •8. Demonstrate acceptable MDI administration technique.
- •9. eDiary compliance 70% or more during screening, defined as completing the daily eDiary and answering Yes to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization.
排除标准
- •1.Life-threatening asthma as 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. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.
- •3. Hospitalization for asthma within 8 weeks 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 (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
- •5. Known history of drug or alcohol abuse within 12 months of Visit 1.
- •6. Use of a nebulizer or a home nebulizer for receiving asthma medications.
- •7. Current smokers, former smokers with over 10 pack-years history, or former smokers who stopped smoking below 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
- •8. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
- •9. For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
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