Expired Study
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Spartanburg, South Carolina 29303


Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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


NCT ID:

NCT00801684


Primary Contact:

Study Director
Bernard L. Silverman, MD
Alkermes


Backup Contact:

N/A


Location Contact:

Spartanburg, South Carolina 29303
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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