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

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

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

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
United States, South Carolina | |
United States Investigational Site | |
Spartanburg, South Carolina, United States |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00465959 |
Other Study ID Numbers: |
IP631-024 |
First Posted: | April 27, 2007 Key Record Dates |
Last Update Posted: | December 27, 2013 |
Last Verified: | July 2011 |
COPD |
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 |