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

NCT ID: NCT00465959

Last Updated: 2013-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-06-30

Brief Summary

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To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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400 mg TrIP

Group Type EXPERIMENTAL

trospium chloride inhalation powder (TrIP)

Intervention Type DRUG

800 mg TrIP

Group Type EXPERIMENTAL

trospium chloride inhalation powder (TrIP)

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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trospium chloride inhalation powder (TrIP)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role collaborator

Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Endo Pharmaceuticals

Locations

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United States Investigational Site

Spartanburg, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IP631-024

Identifier Type: -

Identifier Source: org_study_id