This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
1,009
IV
IV
Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment
FEV1 data was obtained by spirometry measures.
Time frame: 2 Hours post dose
Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE). Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease. The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, \& wheezing.
Time frame: Within 2 Hours of study drug administration
Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE). Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease. The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, \& wheezing.
Time frame: Within 24 Hours of study drug administration
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values
FEV1 data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted
FEV1 data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.
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Unnamed facility
Montgomery, Alabama, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Encinitas, California, United States
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Fullerton, California, United States
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Mission Viejo, California, United States
Unnamed facility
Roseville, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
...and 38 more locations
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)
FVC data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio
FEV1 and FVC data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry
Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.
Time frame: Baseline and Hour 2
Percentage of Selected Respiratory Adverse Events
The selected respiratory Adverse Events are dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea and wheezing. Subjects may have reported more than one type of Adverse Event.
Time frame: Within 24 Hours of study drug administration