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临床试验/NCT00809757
NCT00809757已完成3 期

A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma

Sumitomo Pharma America, Inc.46 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2008年12月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
197
试验地点
46
主要终点
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.

详细描述

This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to <48 months with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
— 至 48 Months（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.
  • •Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules.
  • •Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent.
  • •Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea).
  • •Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease.
  • •Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma.
  • •In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator.
  • •Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion.

排除标准

  • •Subject who requires or is expected to require any disallowed medications
  • •Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial.
  • •Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both.
  • •Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
  • •Subject who has experienced significant blood loss within 60 days of study drug.
  • •Subject with a clinical diagnosis of cystic fibrosis.
  • •Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening
  • •Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000].
  • •Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
  • •Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
  • •Subject with a history of life-threatening asthma, defined as previous asthma episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures.
  • •Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function).
  • •Subject with a history of cancer.
  • •Subject with any chronic or congenital cardiorespiratory condition other than asthma including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis.
  • •Subject affected by an upper or lower respiratory tract infection in the 3 weeks prior to screening.
  • •Subject with a history of ventilation for a respiratory condition occurring at or near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary. - Subject with any clinically significant abnormal laboratory values (hematology, blood chemistry).
  • •Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects.
  • •Subject who is a relative of a staff member.

研究组 & 干预措施

3

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

2

Active Comparator

0.31 ug Levalbuterol UDV TID

干预措施: Levalbuterol UDV TID (Drug)

1

Experimental

90 ug Levalbuterol (2 actuations)

干预措施: Levalbuterol (Drug)

结局指标

主要结局

Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)

时间窗: Baseline, Visit 4 (Week 4)

The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.

次要结局

  • Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3(Baseline, Visit 3, pre -dose (approximately 14 days after randomization))
  • Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4(Baseline, Visit 3 (the week prior to Visit 3) and Visit 4)
  • Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period(Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study))
  • Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment(The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days)
  • Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3(Baseline, Visit 3, pre-dose (approximately 14 days after randomization))
  • Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4(Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose)
  • Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)(Baseline, Visit 3 (Week 3))
  • Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2(Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose)
  • Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2(Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose)
  • Investigator Global Assessment - Question 1(Visit 4 (End of 28 day treatment period))
  • Investigator Global Assessment - Question 2(Visit 4 (End of 28 day treatment period))
  • Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire(The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days)
  • Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire(The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days)
  • Caregiver Global Assessment - Question 1(Visit 4 (End of 28 day treatment period))
  • Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used(Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study))
  • Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score(Visit 3 and Visit 4 (End of 28 day treatment period))
  • Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment(Baseline, Visit 3 (Week 3))
  • Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment(The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days)
  • Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire(Baseline, Visit 4 (Week 4))
  • Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4(Baseline, Visit 4, pre -dose (approximately 28 days after randomization))
  • Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)(Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4))
  • Caregiver Global Assessment - Question 3(Visit 4 (End of 28 day treatment period))
  • Caregiver Global Assessment - Question 2(Visit 4 (End of 28 day treatment period))
  • Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used(Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study))
  • Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week(Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (46)

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