Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
NCT ID: NCT01641081
Last Updated: 2017-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
174 participants
INTERVENTIONAL
2012-06-30
2013-02-28
Brief Summary
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This study will include a screening visit followed by a 4 month treatment period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Experimental 1
Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
Formoterol Fumarate in the Pressair DPI, Low Dose
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Experimental 2
Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose
Formoterol Fumarate in the Pressair DPI, High Dose
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Active Comparator 1
Foradil Aerolizer, Low Dose
Foradil Aerolizer, Low Dose
Foradil Aerolizer 12 micrograms, twice a day for 14 days
Active Comparator 2
Foradil Aerolizer, High Dose
Foradil Aerolizer, High Dose
Foradil Aerolizer 24 micrograms, twice per day for 14 days
Placebo
Dose matched placebo
Placebo
Placebo in the Pressair for 14 days
Interventions
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Formoterol Fumarate in the Pressair DPI, Low Dose
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Formoterol Fumarate in the Pressair DPI, High Dose
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Foradil Aerolizer, Low Dose
Foradil Aerolizer 12 micrograms, twice a day for 14 days
Foradil Aerolizer, High Dose
Foradil Aerolizer 24 micrograms, twice per day for 14 days
Placebo
Placebo in the Pressair for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30 days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the use of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1.
* Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of predicted for age, height, and gender using NHANES III (NHANES 2010) when bronchodilator medications have been withheld the appropriate length of time per the List of Concomitant Medications (Appendix III)
* Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after the administration of 360 µg of albuterol.
* Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the qualifying FEV1 at Visit 1
Exclusions:
* Patients with any clinically significant respiratory conditions other than mild to moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung disease
* Patients with a severe asthma exacerbation requiring hospitalization in the previous 12 months
* Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for at least 6 hours prior to visit
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Garcia, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Forest Investigative Site 909
Phoenix, Arizona, United States
Forest Investigative Site 2066
Encinitas, California, United States
Forest Investigative Site 1624
Los Angeles, California, United States
Forest Investigative Site 1995
Mission Viejo, California, United States
Forest Investigative Site 1347
San Jose, California, United States
Forest Investigative Site 1996
Centennial, Colorado, United States
Forest Investigative Site 1137
Colorado Springs, Colorado, United States
Forest Investigative Site 1998
Denver, Colorado, United States
Forest Investigative Site 2047
Tampa, Florida, United States
Forest Investigative Site 1536
Louisville, Kentucky, United States
Forest Investigative Site 1333
Baltimore, Maryland, United States
Forest Investigative Site 1431
North Dartmouth, Massachusetts, United States
Forest Investigative Site 2041
Minneapolis, Minnesota, United States
Forest Investigative Site 1599
St Louis, Missouri, United States
Forest Investigative Site 1609
Bellevue, Nebraska, United States
Forest Investigative Site 1999
Skillman, New Jersey, United States
Forest Investigative Site 1153
Raleigh, North Carolina, United States
Forest Investigative Site 1134
Canton, Ohio, United States
Forest Investigative Site 1806
Cincinnati, Ohio, United States
Forest Investigative Site 1176
Oklahoma City, Oklahoma, United States
Forest Investigative Site 2043
Medford, Oregon, United States
Forest Investigative Site 1580
Portland, Oregon, United States
Forest Investigative Site 2025
Charleston, South Carolina, United States
Forest Investigative Site 1155
Dallas, Texas, United States
Forest Investigative Site 1332
El Paso, Texas, United States
Forest Investigative Site 1370
New Braunfels, Texas, United States
Forest Investigative Site 1699
San Antonio, Texas, United States
Forest Investigative Site 2011
Seattle, Washington, United States
Forest Investigative Site 1997
Madison, Wisconsin, United States
Countries
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Related Links
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Other Identifiers
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LAC-MD-21
Identifier Type: -
Identifier Source: org_study_id
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