The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,128
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device
Placebo administered via the CRC749 and Diskus devices
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)
The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo
Time frame: 0-12 hours after dosing on Day 1
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)
The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures
Time frame: 0-12 hours after dosing on Day 1
FEV1 Trough Value (Assay Sensitivity)
Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.
Time frame: Day 1 and Day 29
FEV1 Trough Value (Bioequivalence)
Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]
Time frame: Day 1 and Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mylan Investigative Site #1
Birmingham, Alabama, United States
Mylan Investigative Site #2
Little Rock, Arkansas, United States
Mylan Investigative Site #3
Anaheim, California, United States
Mylan Investigative Site #4
Bakersfield, California, United States
Mylan Investigative Site #5
Burbank, California, United States
Mylan Investigative Site #6
Costa Mesa, California, United States
Mylan Investigative Site #7
Encinitas, California, United States
Mylan Investigative Site #8
Fresno, California, United States
Mylan Investigative Site #9
Fullerton, California, United States
Mylan Investigative Site #10
Huntington Beach, California, United States
...and 91 more locations