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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465959
First Posted: April 27, 2007
Last Update Posted: December 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alkermes, Inc.
Information provided by:
Endo Pharmaceuticals
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465959


Locations
United States, South Carolina
United States Investigational Site
Spartanburg, South Carolina, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Alkermes, Inc.
  More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00465959     History of Changes
Other Study ID Numbers: IP631-024
First Submitted: April 24, 2007
First Posted: April 27, 2007
Last Update Posted: December 27, 2013
Last Verified: July 2011

Keywords provided by Endo Pharmaceuticals:
COPD

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