A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
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
1 other identifier
interventional
45
1 country
4
Brief Summary
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2010
CompletedFirst Posted
Study publicly available on registry
April 30, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedMay 27, 2013
May 1, 2013
Same day
April 27, 2010
May 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 hours on Day 1 and Day 7 of dosing during each treatment period
Study Arms (5)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (4)
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Spartanburg, South Carolina, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2010
First Posted
April 30, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2010
Last Updated
May 27, 2013
Record last verified: 2013-05