NCT00530062已完成4 期
Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
研究概览
简要总结
This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma of a minimum of 6 months duration
- •Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
- •Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
- •The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol
- •Ability to perform spirometry reproducibly
- •Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries
- •Can tolerate withdrawal of applicable medications for qualification at screening
- •Otherwise healthy individuals
- •Non-smokers for at least 2 years prior to the screening visit
排除标准
- •Allergy or sensitivity to albuterol
- •Exposure to investigational drugs within 30 days prior to the screening visit
- •Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
- •Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
- •The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
- •Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
- •Hospitalization for acute exacerbation of asthma more than twice in past year
- •Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit
- •An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit
- •History and/or presence of any clinically significant non-asthmatic acute or chronic disease
- •Known or suspected substance abuse
- •Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Albuterol-HFA-BAI
Experimental
Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2.
干预措施: Albuterol-HFA-BAI (Drug)
Albuterol-HFA-MDI
Active Comparator
Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.
干预措施: Albuterol-HFA-MDI (Drug)
结局指标
主要结局
Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
时间窗: Baseline, Up to 2 hours postdose
The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.
次要结局
- Percent Change From Baseline in FEV1 Within 30 Minutes Postdose(Baseline up to 30 minutes postdose)
- Percent Change From Baseline in FEV1 up to 2 Hours Postdose(Baseline up to 2 hours postdose)
- Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2(Baseline up to 2 hours postdose)
- Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
- Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
- Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
- Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
- Time to Maximum Increase in FEV1(Baseline up to 2 hours postdose)
研究者
研究点 (2)
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