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

This study has been completed.

First Received on April 24, 2007. Last Updated on July 15, 2011 History of Changes

Sponsor:	Endo Pharmaceuticals
Collaborator:	Alkermes
Information provided by:	Endo Pharmaceuticals
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) Drug: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

Primary Outcome Measures:

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

Enrollment:	24
Study Start Date:	April 2007
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 400 mg TrIP	Drug: trospium chloride inhalation powder (TrIP)
Experimental: 800 mg TrIP	Drug: trospium chloride inhalation powder (TrIP)
Placebo Comparator: Placebo	Drug: Placebo

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

Alkermes

More Information

No publications provided

Responsible Party:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00465959 History of Changes
Other Study ID Numbers:	IP631-024
Study First Received:	April 24, 2007
Last Updated:	July 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Trospium chloride
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012