Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).
详细描述
This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a 4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E was administered in an open-label fashion as the final dose in each dosing sequence for all subjects.
Subjects reported to the clinic the evening prior to each dose. Protocol assessments were carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. Other efficacy and safety outcomes were assessed according to protocol. Blood sampling was performed for assessment of trospium concentrations at specified timepoints.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female COPD subjects between the ages of 40 and 80 years
- •Body mass index between 18 and 35
- •Medically healthy (other than COPD)
- •FEV1/FVC less than or equal to 0.70
- •Current non-smoker or able to abstain from smoking for at least 8 hours postdose
- •Within the previous 6 months, demonstrated improvement in FEV1 (greater than or equal to 10%) 1 hour following administration of ipratropium bromide inhalation (4 puffs)
- •Females of childbearing potential must agree to use an acceptable method of contraception for the duration of the study
排除标准
- •Asthma in the last 10 years
- •Allergic rhinitis, atopy, cystic fibrosis, bronchiectasis, or tuberculosis
- •Bladder neck obstruction, including urinary retention or known symptomatic prostatic hypertrophy not controlled with medication
- •Narrow angle glaucoma
- •Tachyarrhythmia
- •Alcohol dependence or illicit drug abuse within the past year
- •Using long-term oxygen therapy
- •Female subjects who are pregnant or breastfeeding
- •Participating in another clinical trial
研究组 & 干预措施
Placebo
Represents Dose A in the Dosing Sequence assignments.
干预措施: Placebo (Drug)
TrIP-2D (100mcg)
Represents Dose B
干预措施: TrIP-2D (Drug)
TrIP-2SS (100mcg)
Represents Dose C
干预措施: TrIP-2SS (Drug)
TrIP-2D (400mcg)
Represents Dose D
干预措施: TrIP-2D (Drug)
TrIP-2SS (100mcg) + Foradil (12mcg)
Represents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment.
干预措施: TrIP-2SS + Foradil (Drug)
结局指标
主要结局
Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)
时间窗: 15 minutes to 24 hours post-treatment
Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. The dosing formulations were as follows: Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose.
次要结局
- FEV1 Response to Treatment(Up to 24 hours post-treatment)
- Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP(up to 24 hours post-treatment)