Back to resultsStudy of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
trospium chloride inhalation powder (TrIP)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility 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
Sites / Locations
- United States Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
400 mg TrIP
800 mg TrIP
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
Secondary Outcome Measures
Full Information
NCT ID
NCT00465959
First Posted
April 24, 2007
Last Updated
December 3, 2013
Sponsor
Endo Pharmaceuticals
Collaborators
Alkermes, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00465959
Brief Title
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Endo Pharmaceuticals
Collaborators
Alkermes, Inc.
4. Oversight
5. Study Description
Brief Summary
To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
400 mg TrIP
Arm Type
Experimental
Arm Title
800 mg TrIP
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
trospium chloride inhalation powder (TrIP)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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
Facility Information:
Facility Name
United States Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
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