Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Information source: Indevus Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: trospium chloride inhalation powder (TrIP) (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Indevus Pharmaceuticals
Summary
To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD
Clinical Details
Official title: Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female COPD patients between the ages of 40 and 80 years
- Smoking history of at least 10 pack years
- Not currently using (or able to wash out of) any long acting bronchodilators
Exclusion Criteria:
- Candidate on a waiting list for surgery while on study
- Using long-term oxygen therapy
- Hospitalization for COPD exacerbation
Locations and Contacts
United States Investigational Site, Spartanburg, South Carolina, United States
Additional Information
Starting date: April 2007
Last updated: July 3, 2007
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