A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国
- Teva Investigational Site 10077
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Arizona
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Phoenix、Arizona、美国
- Teva Investigational Site 10079
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California
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Costa Mesa、California、美国
- Teva Investigational Site 10569
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Fountain Valley、California、美国
- Teva Investigational Site 10053
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Huntington Beach、California、美国
- Teva Investigational Site 10065
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Huntington Beach、California、美国
- Teva Investigational Site 10572
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Los Angeles、California、美国
- Teva Investigational Site 10075
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Roseville、California、美国
- Teva Investigational Site 10061
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San Diego、California、美国
- Teva Investigational Site 10066
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Colorado
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Denver、Colorado、美国
- Teva Investigational Site 10068
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Denver、Colorado、美国
- Teva Investigational Site 10069
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Florida
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Miami、Florida、美国
- Teva Investigational Site 10058
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Miami、Florida、美国
- Teva Investigational Site 10060
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Ormond Beach、Florida、美国
- Teva Investigational Site 10064
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Georgia
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Savannah、Georgia、美国
- Teva Investigational Site 10071
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Kansas
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Wichita、Kansas、美国
- Teva Investigational Site 10073
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Kentucky
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Owensboro、Kentucky、美国
- Teva Investigational Site 10070
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Maryland
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Bethesda、Maryland、美国
- Teva Investigational Site 10063
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Gaithersburg、Maryland、美国
- Teva Investigational Site 10571
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Wheaton、Maryland、美国
- Teva Investigational Site 10067
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Missouri
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St. Louis、Missouri、美国
- Teva Investigational Site 10072
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Montana
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Missoula、Montana、美国
- Teva Investigational Site 10050
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North Carolina
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Raleigh、North Carolina、美国
- Teva Investigational Site 10057
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Ohio
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Cincinnati、Ohio、美国
- Teva Investigational Site 10051
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Sylvania、Ohio、美国
- Teva Investigational Site 10078
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Oklahoma
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Oklahoma City、Oklahoma、美国
- Teva Investigational Site 10054
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Oklahoma City、Oklahoma、美国
- Teva Investigational Site 10568
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Tulsa、Oklahoma、美国
- Teva Investigational Site 10055
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Oregon
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Medford、Oregon、美国
- Teva Investigational Site 10056
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Medford、Oregon、美国
- Teva Investigational Site 10076
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South Carolina
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Charleston、South Carolina、美国
- Teva Investigational Site 10684
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Spartanburg、South Carolina、美国
- Teva Investigational Site 10570
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Texas
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Live Oak、Texas、美国
- Teva Investigational Site 10049
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San Antonio、Texas、美国
- Teva Investigational Site 10052
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Waco、Texas、美国
- Teva Investigational Site 10685
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Virginia
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Fairfax、Virginia、美国
- Teva Investigational Site 10059
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Washington
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Puyallup、Washington、美国
- Teva Investigational Site 10074
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Tacoma、Washington、美国
- Teva Investigational Site 10062
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Written informed consent/assent
- General good health
- Persistent asthma, with an FEV1 50-80% predicted.
- Ability to perform spirometry in an acceptable manner as per protocol guidelines.
- Ability to perform PEFR with a handheld peak flow meter.
- Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
- Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
- Non-smokers.
- Capable of understanding the requirements, risks, and benefits of study participation.
- Other inclusion criteria apply.
Exclusion Criteria:
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
- A known hypersensitivity to albuterol or any of the excipients in the formulations.
- History of severe milk protein allergy.
- History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
- Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
- History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
- Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
- Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
- Other exclusion criteria apply.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
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Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
其他名称:
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实验性的:Albuterol MDPI
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
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Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
大体时间:Day 1, Day 8 and Day 85
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 1, Day 8 and Day 85
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
大体时间:Day 1
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 1
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
大体时间:Day 8
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 8
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
大体时间:Day 85
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 85
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Participants With Adverse Events
大体时间:Day 1 to Day 92
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Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs).
An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities.
Relation of AE to treatment was determined by the investigator.
Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
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Day 1 to Day 92
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Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
大体时间:Day 1 (Baseline), Day 85
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Physical exam was recorded as normal or abnormal based on physician assessment.
Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat
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Day 1 (Baseline), Day 85
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Participants With Clinically Significant Vital Sign Assessments
大体时间:Day 8, Day 85
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For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min). Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant: Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute |
Day 8, Day 85
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
大体时间:Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Percent Change From Baseline in FEV1 AUC 0-6
大体时间:Day 1
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Day 1
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Percent Change From Baseline in FEV1 AUC
大体时间:Day 8
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Day 8
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Percent Change From Baseline in FEV1 AUC
大体时间:Day 85
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Day 85
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
大体时间:Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1
大体时间:Day 1
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Day 1
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
大体时间:Day 8
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Day 8
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
大体时间:Day 85
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Day 85
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Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
大体时间:Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes
大体时间:Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes
大体时间:Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Duration of Response on Days 1, 8 and 85
大体时间:Day 1, Day 8, Day 85
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Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes
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Day 1, Day 8, Day 85
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Percent of Symptom Free Days on the Patient Diary
大体时间:Treatment days 1 through 85
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Treatment days 1 through 85
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Percent of Rescue Medication Free Days in the Patient Diary
大体时间:Treatment days 1 through 85
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Treatment days 1 through 85
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Morning Peak Expiratory Flow Reading Reported on Patient Diary
大体时间:Treatment days 1 through 85
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Treatment days 1 through 85
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Placebo MDPI的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的