Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease - Tabular View

Tracking Information
First Received Date ^ICMJE	April 24, 2007
Last Updated Date	January 3, 2009
Start Date ^ICMJE	April 2007
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 25, 2007)	Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00465959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Official Title ^ICMJE	Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary	To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE	Drug: trospium chloride inhalation powder (TrIP)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	24
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00465959
Responsible Party	Mark Roessel, VP Regulatory Affairs, Indevus Pharmaceuticals, Inc.
Study ID Numbers ^ICMJE	IP631-024
Study Sponsor ^ICMJE	Endo Pharmaceuticals Solutions Inc.
Collaborators ^ICMJE	Alkermes
Investigators ^ICMJE
Information Provided By	Endo Pharmaceuticals Solutions Inc.
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP