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

This study has been completed.

First Received: April 24, 2007 Last Updated: January 3, 2009 History of Changes

Sponsor:	Endo Pharmaceuticals Solutions Inc.
Collaborator:	Alkermes
Information provided by:	Endo Pharmaceuticals Solutions Inc.
ClinicalTrials.gov Identifier:	NCT00465959

Purpose

To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: trospium chloride inhalation powder (TrIP)	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Chlorides

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals Solutions Inc.:

Primary Outcome Measures:

Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.

Estimated Enrollment:	24
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465959

Locations

United States, South Carolina
United States Investigational Site
Spartanburg, South Carolina, United States

Sponsors and Collaborators

Endo Pharmaceuticals Solutions Inc.

Alkermes

More Information

No publications provided

Responsible Party:	Indevus Pharmaceuticals, Inc. ( Mark Roessel, VP Regulatory Affairs )
Study ID Numbers:	IP631-024
Study First Received:	April 24, 2007
Last Updated:	January 3, 2009
ClinicalTrials.gov Identifier:	NCT00465959 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals Solutions Inc.:

COPD

Additional relevant MeSH terms:

Parasympatholytics
Respiration Disorders
Physiological Effects of Drugs
Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Sensory System Agents

Therapeutic Uses
Lung Diseases
Trospium chloride
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009