- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465959
Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
December 3, 2013 updated by: Endo Pharmaceuticals
Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Spartanburg, South Carolina, United States
- United States Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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EXPERIMENTAL: 400 mg TrIP
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EXPERIMENTAL: 800 mg TrIP
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (ACTUAL)
June 1, 2007
Study Completion (ACTUAL)
June 1, 2007
Study Registration Dates
First Submitted
April 24, 2007
First Submitted That Met QC Criteria
April 25, 2007
First Posted (ESTIMATE)
April 27, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
December 27, 2013
Last Update Submitted That Met QC Criteria
December 3, 2013
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Trospium chloride
Other Study ID Numbers
- IP631-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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