Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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