Back to resultsA Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Formoterol Fumarate
Formoterol Fumarate
Formoterol Fumarate
Foradil Aerolizer
Foradil Aerolizer
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Able to understand the requirements of the study and provide informed consent
- A Clinical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study
Exclusion Criteria:
- A Clinical Diagnosis of Asthma
- Other significant disease than COPD
- Subjects who radiation or chemotherapy within the previous 12 months
- Subjects who had any lung resection
- QTcB greater than 0.460 seconds
- History of illegal drug abuse or alcohol abuse within the past 5 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
Outcomes
Primary Outcome Measures
Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01113593
Brief Title
A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
Official Title
A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dey
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Intervention Description
Inhalation solution
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Intervention Description
Inhalation solution
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Intervention Description
Inhalation solution
Intervention Type
Drug
Intervention Name(s)
Foradil Aerolizer
Intervention Description
Dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Foradil Aerolizer
Intervention Description
Dry powder inhaler
Primary Outcome Measure Information:
Title
Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil
Time Frame
12 hours on Day 1 and Day 7 of dosing during each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand the requirements of the study and provide informed consent
A Clinical diagnosis of COPD
A current or prior history of at least 10-pack years of cigarette smoking
women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study
Exclusion Criteria:
A Clinical Diagnosis of Asthma
Other significant disease than COPD
Subjects who radiation or chemotherapy within the previous 12 months
Subjects who had any lung resection
QTcB greater than 0.460 seconds
History of illegal drug abuse or alcohol abuse within the past 5 years
Facility Information:
City
Clearwater
State/Province
Florida
Country
United States
City
Deland
State/Province
Florida
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Spartanburg
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
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