The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
Institute of Healthcare Assessment, Inc
San Diego, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Waterbury Pulmonary Associates
Waterbury, Connecticut, United States
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time frame: Days 0 - 150
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Time frame: Days 0 - 150
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants with ADA to MEDI-528
Time frame: Days 0, 28, 56, 119, and 150
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
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Univ. of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States
Sneeze,Wheeze & Itch Associates, LLC
Normal, Illinois, United States
Northeast Medical Research Associates, Inc
No. Dartmouth, Massachusetts, United States
The Clinical Research Center, LLC
St Louis, Missouri, United States
Creighton University
Omaha, Nebraska, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
Calgary COPD & Asthma Program
Calgary, Alberta, Canada
...and 2 more locations
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
AUC of FEV1 at Day 28
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
AUC of FEV1 at Day 56
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
AUC of FEV1 at Day 150
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28
Time frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56
Time frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150
Time frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)
Mean Trough Concentration (Cmin)
Cmin of MEDI-528
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Mean Trough Concentration at Last Measurable Time Point (Cmin_last)
Cmin\_last of MEDI-528
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Half-life (T1/2)
T1/2 of MEDI-528
Time frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150
Accumulation Index
Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528
Time frame: Days 0 and 24