Back to resultsStudy in Patients With COPD
Primary Purpose
COPD, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Formoterol Fumarate
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Formoterol Fumarate, Formoterol
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD History of cigarette smoking Exclusion Criteria: Clinical diagnosis of asthma Significant pulmonary disease other than COPD Other significant major organ disease(s)
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Measure of lung function
Secondary Outcome Measures
Change in lung function, as well as vital signs
Physical Exam results, adverse event reporting, etc
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00215423
Brief Title
Study in Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dey
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Chronic Obstructive Pulmonary Disease
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Formoterol Fumarate, Formoterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
49 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Primary Outcome Measure Information:
Title
Measure of lung function
Secondary Outcome Measure Information:
Title
Change in lung function, as well as vital signs
Title
Physical Exam results, adverse event reporting, etc
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
History of cigarette smoking
Exclusion Criteria:
Clinical diagnosis of asthma
Significant pulmonary disease other than COPD
Other significant major organ disease(s)
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2666
Country
United States
Facility Name
Research Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Research Site
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Research Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66216
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18655841
Citation
Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8.
Results Reference
result
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Study in Patients With COPD
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