Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
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
NCT number | NCT01113593 |
Other study ID # | 191-089 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | April 27, 2010 |
Last updated | May 17, 2013 |
Start date | May 2010 |
Verified date | May 2013 |
Source | Dey |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
Status | Completed |
Enrollment | 45 |
Est. completion date | |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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