Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.
This is a randomized, six-way crossover study to determine the efficacy and dose-response profile of SUN101. The study population will consist of subjects 40 to 65 years-old (inclusive), with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg bid will be given as an active comparator. The study will be double-blind for SUN-101 and placebo and will be open-label for aclidinium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
American Health Research, Inc.
Charlotte, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period
Time frame: Baseline and Day 7
Standardized Change From Baseline in FEV1 AUC(0-12hours)
The standardized FEV1 AUC(0-12) on Day 7 was calculated using the trapezoidal rule from the changes in FEV1 from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval).
Time frame: Day 7
Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.
Time frame: Over 7 days
Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)
A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.
Time frame: Over 7 days
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SUN-101 12.5 mcg bid
SUN-101 50 mcg bid
Aclidinium 400 mcg bid
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Palmetto Medical Research Associates, LLC
Easley, South Carolina, United States
Greenville Pharmaceutical Research, Inc.
Greenville, South Carolina, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
S. Carolina
Spartanburg, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
CU Pharmaceutical Research
Union, South Carolina, United States