NCT00634517终止3 期
A Multi-Center, Randomized, Double-Blind, Active-Controlled, Parallel Group, 4-Week Study to Evaluate the Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Patients With Asthma in Pediatric Patients With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- The primary endpoint for efficacy evaluation is to obtain the ratio of the geometric mean of area under the curve of change in FEV1%versus time for pediatric patients using the study drug to the active reference drug.
研究概览
简要总结
This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals, Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition, pharmacokinetic profile in this population will be evaluated using a population PK approach with sparse blood samples.
详细描述
This study consists of two periods:
- Run-in Period (7-14 days): During the Run-in Period, subjects will maintain their current inhaled short-acting B2-agonist and inhaled corticosteroid therapies. All long-acting b-agonists (LABA) will be prohibited and replaced with a short-acting B2-agonist (Ventolin-HFA) and an inhaled corticosteroid, for a minimum of 7 days. Such LABA replacement therapy is not considered as violation of the asthma stability. The current orally inhaled corticosteroids may be maintained at the prescribed dosing regimen. All concomitant medications must be compliant or adjusted to the restrictions and washout time limits per Appendix II. Subjects will document their daily asthma symptom scores, treatment regimens, concomitant medications, PEF records, and adverse events if any.
- Study Period (4 wk): During the 4-week Study Period, subjects will be randomized into one of the following 2 double-blinded treatment groups:
- Treatment T (Albuterol-HFA, N=24): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), oral inhalation, QID;
- Treatment R (Proventil-HFA, N=24): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), oral inhalation, QID.
During the Study Period, subjects will document their daily asthma symptom scores, treatment regimens, concomitant medications, PEF records, and adverse events if any. Three Clinical Visits are to be conducted, for measurement of treatment efficacy with serial spirometry (at Clinical Visit 1 and 3); for monitoring safety and compliance (at Clinical Visit 1, 2 and 3); and for evaluating pharmacokinetic profiles in part of the study population (greater than or equal to 6 subjects per Arm) using a population PK approach (PPK) with a sparse blood sampling regimen (at Clinical Visit 3).
STUDY POPULATION
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally healthy.
- •Male and female mild-to-moderate asthma patients.
- •Aged 4 - 11 yr (upon screening).
- •Female patients must be premenarchal upon Visit-1, and those who become menarchal during the study must use an accepted method of contraception including abstinence.
- •A documented history of asthma, for at-least 6-months prior to Screening, requiring inhaled B-adrenergic agonists, with or without inhaled corticosteroids for asthma symptom control.
- •Satisfying asthma stability criterion, defined as no changes in asthma therapy and no asthma-related hospitalization or emergency room visits, over the 4 weeks prior to Screening.
- •Being able to withhold treatment with inhaled bronchodilators and/or restricted medications for the minimum washout periods indicated in Appendix II, for the purpose of conducting clinical visits.
- •Having a baseline forced expiratory volume in 1 second (FEV1), that is 50.0-100.0% of predicted values at the screening (Screening Baseline FEV1).
- •Demonstrating a greater than or equal to 12.0% reversibility in the Reversibility Test, at 30 min after inhaling 2-4 puffs (180-360 mcg) of Ventolin-HFA.
- •Demonstrating correct use of metered-dose inhaler (MDIs), and acceptable performance in the FEV1 measurements.
- •Has properly consented, with a parent or a legal guardian, to participate in this study.
排除标准
- •Any current or past significant medical conditions that, according to the investigator, might affect pharmacodynamic response to the study drugs, such as significant systemic or respiratory diseases (e.g., cystic fibrosis, bronchiectasis, emphysema, nonreversible pulmonary diseases), other than asthma.
- •Concurrent clinically significant cardiovascular, hematological, renal, neurological, hepatic, and endocrine disorders, or psychiatric diseases.
- •Known intolerance or hypersensitivity to any component of the MDI formulation (e.g., albuterol, HFA-134a, oleic acid, ethanol).
- •Recent upper (within 2 weeks) or lower (within 4 weeks) respiratory tract infection before screening.
- •Recent (within 4 weeks) use of systemic (or oral) corticosteroids and B-adrenergic bronchodilators; or recent (within 2 weeks) use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), or B-blockers; before the Screening.
- •Having been on other investigational drug/device studies in the last 30 days prior to screening.
- •Known or reasonably suspected alcohol/drug abuses.
- •Having smoked within the last 12 months.
研究组 & 干预措施
T
Experimental
Armstrong Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).
干预措施: Armstrong Albuterol Sulfate Inhalation Aerosol (Drug)
R
Active Comparator
Proventil-HFA, Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).
干预措施: Albuterol Sulfate Inhalation Aerosol (Drug)
结局指标
主要结局
The primary endpoint for efficacy evaluation is to obtain the ratio of the geometric mean of area under the curve of change in FEV1%versus time for pediatric patients using the study drug to the active reference drug.
时间窗: visits 1 and 3
次要结局
- AUC of serial FEV1 volume changes from the Same Day Baseline versus time, during the 6-hr post-dose.(each visit)
- Time to onset of bronchodilator effect, determined by linear interpolation as the time point when FEV1 first exceeded 12.0% over the respective Same Day Baseline.(each visist)
- The peak bronchodilator response, Fmax, defined as the maximum FEV1 (% change from the Same Day Baseline).(each visit)
- Duration of bronchodilator effect, defined as the total duration when FEV1 is maintained greater than or equal to 12.0% above the respective Same Day Baseline values.(each visit)
- Pharmacokinetic parameters including Cmax, AUC, and t1/2, based on a population pharmacokinetic (PPK) approach with sparse blood samples, conducted at Clinical Visit 3.(visit 3)
- Requirements for rescue/concomitant medications, for each treatment group(end of study)
- The time to peak bronchodilator response (FEV1), with Fmax defined as the maximum FEV1 (% change from the Same Day Baseline).(each visit)
- Nighttime sleep disturbance scores(end of study)
- (6) Percentage of positive responders including those whose FEV1 exceed the Same-Day Baseline by greater than or equal to 12.0% at or before 30 min post-dose (quick responders), and at any time during the entire 6 hr post-dose (overall responders).(each visit)
- Vital signs (SBP/DBP, and heart rate) will be monitored at: 1. baseline (prior to dosing), and; 2. 60 minutes post-dose, but before the 60 min FEV1 tests. 3. 360 minutes post-dose, but before the 360 min FEV1 tests.(Screening, visits 1 and 3)
- lab tests for CBC, blood metabolic panel, and urinalysis.(Pre-study and end of study)
- Mean Overall Asthma Control Scores evaluated by investigators(end of study)
- Total daytime asthma symptom scores(end of study)
- Morning and evening pre-dose Peak Expiratory Flow Rate (PEF).(end of study)
- Physical examinations(Screening and end of study)
- Study compliance and safety will be reviewed. Concomitant medications will be reviewed and recorded(All Study Visits)
- Number of asthma exacerbations during the entire study period(end of study)
- Adverse events, whether observed by investigators or reported by subjects, will be documented and followed up if deemed necessary.(At All Study Visits)
- A 12-lead ECG (HR, QT and QTc intervals) recorded at: 1. pre-dose, and; 2. 60 minutes post-dose, but before the 60 min FEV1 tests.(Screening and visits 1 and 3)
- Blood potassium levels(Screening and EOS for all subjects; and at 120+15 min post dose (Visit 3) for population PK subjects only)
研究者
研究点 (8)
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