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

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ClinicalTrials.gov Identifier: NCT00465959
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
Endo Pharmaceuticals

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: trospium chloride inhalation powder (TrIP) Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
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Information from the National Library of Medicine

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00465959     History of Changes
Other Study ID Numbers: IP631-024
First Posted: April 27, 2007    Key Record Dates
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