Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.
This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
147
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
Time frame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline to Last 7 Days of Treatment Period
Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA
Change from baseline in mean number of puffs of rescue Ventolin HFA
Time frame: Baseline to Last 7 Days of Treatment
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score
The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum
Time frame: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
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Budesonide Inhalation Aerosol administered as 2 inhalations BID
Placebo MDI administered as 2 inhalations BID
Pearl Therapeutics Study Site
Athens, Alabama, United States
Pearl Therapeutics Study Site
Birmingham, Alabama, United States
Pearl Therapeutics Study Site
Foley, Alabama, United States
Pearl Therapeutics Study Site
Los Angeles, California, United States
Pearl Therapeutics
Los Angeles, California, United States
Pearl Therapeutics Study Site
Rolling Hills Estates, California, United States
Pearl Therapeutics Study Site
San Diego, California, United States
Pearl Therapeutics Study Site
Stockton, California, United States
Pearl Therapeutics Study Site
Clearwater, Florida, United States
Pearl Therapeutics Study Site
Clermont, Florida, United States
...and 31 more locations