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

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00465959
First received: April 24, 2007
Last updated: December 3, 2013
Last verified: July 2011
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
  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: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Trospium chloride
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014