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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: trospium chloride inhalation powder (TrIP); Drug: Placebo

• Registration Number: NCT00465959
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-24
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2011-07
• Disposition First Submitted: 2013-12-03
• Disposition First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Disposition First Posted: 2013-12-27
• Last Update Posted: 2013-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
400 mg TrIP	trospium chloride inhalation powder (TrIP)	-
800 mg TrIP	trospium chloride inhalation powder (TrIP)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.

Trial Locations

Locations (1)

United States Investigational Site; 🇺🇸 Spartanburg, South Carolina, United States