Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Collaborator:
Alkermes, Inc.
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00465959
First received: April 24, 2007
Last updated: December 3, 2013
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465959
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465959
Locations
| United States, South Carolina | |
| United States Investigational Site | |
| Spartanburg, South Carolina, United States | |
Sponsors and Collaborators
Endo Pharmaceuticals
Alkermes, Inc.
More Information
No publications provided
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00465959 History of Changes |
| Other Study ID Numbers: | IP631-024 |
| Study First Received: | April 24, 2007 |
| Last Updated: | December 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endo Pharmaceuticals:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Trospium chloride Autonomic Agents Cholinergic Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action |
Muscarinic Antagonists Neurotransmitter Agents Parasympatholytics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Urological Agents |
ClinicalTrials.gov processed this record on March 03, 2015