Trial Outcomes & Findings for A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (NCT NCT00862641)

NCT ID: NCT00862641

Last Updated: 2012-09-18

Results Overview

FEV1 data was obtained by spirometry measures.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1009 participants
• Primary outcome timeframe: 2 Hours post dose
• Results posted on: 2012-09-18

Participant Flow

Participant milestones

Measure	Placebo - Asthma Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Overall Study STARTED	177	360	152	320
Overall Study COMPLETED	176	356	151	316
Overall Study NOT COMPLETED	1	4	1	4

Reasons for withdrawal

Measure	Placebo - Asthma Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Overall Study Randomized, but drug not received	1	4	1	4

Baseline Characteristics

A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Total n=999 Participants Total of all reporting groups
Age, Customized Between 18 and 64 years	148 participants n=5 Participants	304 participants n=7 Participants	95 participants n=5 Participants	189 participants n=4 Participants	736 participants n=21 Participants
Age, Customized >=65 years	28 participants n=5 Participants	52 participants n=7 Participants	56 participants n=5 Participants	127 participants n=4 Participants	263 participants n=21 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	245 Participants n=7 Participants	67 Participants n=5 Participants	132 Participants n=4 Participants	559 Participants n=21 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	111 Participants n=7 Participants	84 Participants n=5 Participants	184 Participants n=4 Participants	440 Participants n=21 Participants
Race/Ethnicity, Customized White	128 Participants n=5 Participants	283 Participants n=7 Participants	136 Participants n=5 Participants	284 Participants n=4 Participants	831 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	45 Participants n=5 Participants	61 Participants n=7 Participants	13 Participants n=5 Participants	22 Participants n=4 Participants	141 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian - Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: 2 Hours post dose

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

FEV1 data was obtained by spirometry measures.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment	2.9 Percentage of Subjects	1.1 Percentage of Subjects	5.4 Percentage of Subjects	4.2 Percentage of Subjects

SECONDARY outcome

Timeframe: Within 2 Hours of study drug administration

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

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.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration	1 Subjects	1 Subjects	2 Subjects	2 Subjects

SECONDARY outcome

Timeframe: Within 24 Hours of study drug administration

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

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.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration	2 Subjects	5 Subjects	2 Subjects	5 Subjects

SECONDARY outcome

Timeframe: Baseline and Hour 2

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each time point is noted in the category titles, as "N".

FEV1 data was obtained by spirometry measurements.

Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values Baseline (N=176; 356; 151; 316)	2.41 Liters Standard Deviation 0.689	2.35 Liters Standard Deviation 0.623	1.70 Liters Standard Deviation 0.630	1.70 Liters Standard Deviation 0.655
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values Hour 2 (N=174; 351; 147; 313)	2.37 Liters Standard Deviation 0.677	2.33 Liters Standard Deviation 0.615	1.69 Liters Standard Deviation 0.651	1.70 Liters Standard Deviation 0.647
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values Change at Hour 2 (N=174; 351; 147; 313)	-0.05 Liters Standard Deviation 0.160	-0.01 Liters Standard Deviation 0.129	-0.01 Liters Standard Deviation 0.152	0.00 Liters Standard Deviation 0.159

SECONDARY outcome

Timeframe: Baseline and Hour 2

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as "N".

FEV1 data was obtained by spirometry measurements.

Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted Baseline (N=176; 356; 151; 316)	81.34 Percentage of Predicted FEV1 Standard Deviation 13.679	80.32 Percentage of Predicted FEV1 Standard Deviation 12.990	55.67 Percentage of Predicted FEV1 Standard Deviation 15.131	55.69 Percentage of Predicted FEV1 Standard Deviation 16.775
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted Hour 2 (N=174; 351; 147; 313)	79.91 Percentage of Predicted FEV1 Standard Deviation 13.591	80.11 Percentage of Predicted FEV1 Standard Deviation 13.324	54.89 Percentage of Predicted FEV1 Standard Deviation 15.601	55.61 Percentage of Predicted FEV1 Standard Deviation 16.843
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted Change at Hour 2 (N=174; 351; 147; 313)	-1.56 Percentage of Predicted FEV1 Standard Deviation 5.368	-0.17 Percentage of Predicted FEV1 Standard Deviation 4.519	-0.56 Percentage of Predicted FEV1 Standard Deviation 4.846	-0.06 Percentage of Predicted FEV1 Standard Deviation 5.170

SECONDARY outcome

Timeframe: Baseline and Hour 2

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as "N".

FVC data was obtained by spirometry measurements.

Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) Baseline (N=176; 356; 151; 316)	3.22 Liters Standard Deviation 0.883	3.16 Liters Standard Deviation 0.829	2.75 Liters Standard Deviation 0.833	2.83 Liters Standard Deviation 0.889
Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) Hour 2 (N=174; 351; 147; 313)	3.17 Liters Standard Deviation 0.887	3.11 Liters Standard Deviation 0.809	2.70 Liters Standard Deviation 0.856	2.84 Liters Standard Deviation 0.857
Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) Change at Hour 2 (N=174; 351; 147; 313)	-0.06 Liters Standard Deviation 0.208	-0.03 Liters Standard Deviation 0.168	-0.04 Liters Standard Deviation 0.230	0.00 Liters Standard Deviation 0.239

SECONDARY outcome

Timeframe: Baseline and Hour 2

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as "N".

FEV1 and FVC data was obtained by spirometry measurements.

Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio Change at Hour 2 (N=174; 351; 147; 313)	0.16 Percentage of FEV1 / FVC Standard Deviation 3.329	0.52 Percentage of FEV1 / FVC Standard Deviation 2.562	0.31 Percentage of FEV1 / FVC Standard Deviation 3.177	-0.30 Percentage of FEV1 / FVC Standard Deviation 3.571
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio Baseline (N=176; 356; 151; 316)	74.88 Percentage of FEV1 / FVC Standard Deviation 7.510	74.59 Percentage of FEV1 / FVC Standard Deviation 7.084	61.95 Percentage of FEV1 / FVC Standard Deviation 12.684	60.00 Percentage of FEV1 / FVC Standard Deviation 13.191
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio Hour 2 ( N=174; 351; 147; 313)	75.11 Percentage of FEV1 / FVC Standard Deviation 7.898	75.09 Percentage of FEV1 / FVC Standard Deviation 7.074	62.26 Percentage of FEV1 / FVC Standard Deviation 12.907	59.72 Percentage of FEV1 / FVC Standard Deviation 13.171

SECONDARY outcome

Timeframe: Baseline and Hour 2

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as "N".

Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry Baseline (N=170; 350; 143; 302)	96.3 Percentage of Oxygen Saturation Standard Deviation 1.81	96.3 Percentage of Oxygen Saturation Standard Deviation 1.81	94.7 Percentage of Oxygen Saturation Standard Deviation 2.40	95.0 Percentage of Oxygen Saturation Standard Deviation 2.45
Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry Hour 2 (N=170; 349; 143; 299)	95.9 Percentage of Oxygen Saturation Standard Deviation 1.80	96.0 Percentage of Oxygen Saturation Standard Deviation 1.78	94.2 Percentage of Oxygen Saturation Standard Deviation 2.25	94.5 Percentage of Oxygen Saturation Standard Deviation 2.18
Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry Change at Hour 2 (N=170; 349; 143; 299)	-0.4 Percentage of Oxygen Saturation Standard Deviation 1.47	-0.4 Percentage of Oxygen Saturation Standard Deviation 1.35	-0.4 Percentage of Oxygen Saturation Standard Deviation 1.42	-0.5 Percentage of Oxygen Saturation Standard Deviation 1.66

SECONDARY outcome

Timeframe: Within 24 Hours of study drug administration

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

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.

Outcome measures

Measure	Placebo - Asthma n=176 Participants Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 Participants Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 Participants 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Percentage of Selected Respiratory Adverse Events Dyspnoea	1.1 Percentage of Subjects	10.7 Percentage of Subjects	2.6 Percentage of Subjects	18.0 Percentage of Subjects
Percentage of Selected Respiratory Adverse Events Wheezing	1.1 Percentage of Subjects	3.1 Percentage of Subjects	0.7 Percentage of Subjects	0.9 Percentage of Subjects
Percentage of Selected Respiratory Adverse Events Obstructive Airways Disorder	0 Percentage of Subjects	0.3 Percentage of Subjects	0 Percentage of Subjects	0 Percentage of Subjects
Percentage of Selected Respiratory Adverse Events Dyspnoea Exertional	0 Percentage of Subjects	0 Percentage of Subjects	0.7 Percentage of Subjects	0 Percentage of Subjects
Percentage of Selected Respiratory Adverse Events Tachypnoea	0 Percentage of Subjects	0 Percentage of Subjects	0 Percentage of Subjects	0.3 Percentage of Subjects

Adverse Events

Placebo - Asthma

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Regadenoson - Asthma

Serious events: 2 serious events

Other events: 212 other events

Deaths: 0 deaths

Placebo - COPD

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Regadenoson - COPD

Serious events: 4 serious events

Other events: 177 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo - Asthma n=176 participants at risk Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 participants at risk 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 participants at risk Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 participants at risk 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Cardiac disorders Atrioventricular block complete	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.28% 1/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Cardiac disorders Bradycardia	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.32% 1/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Investigations Electrocardiogram change	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.32% 1/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Renal and urinary disorders Nephrolithiasis	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.32% 1/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.28% 1/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.32% 1/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.

Other adverse events

Measure	Placebo - Asthma n=176 participants at risk Matching intravenous (IV) bolus injection, subjects with Asthma	Regadenoson - Asthma n=356 participants at risk 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Placebo - COPD n=151 participants at risk Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Regadenoson - COPD n=316 participants at risk 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Nervous system disorders Headache	9.7% 17/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	27.2% 97/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	7.9% 12/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	19.6% 62/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Nervous system disorders Dizziness	4.5% 8/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	19.4% 69/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	2.6% 4/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	14.2% 45/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Nervous system disorders Dysgeusia	7.4% 13/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	9.3% 33/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	4.0% 6/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	9.2% 29/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
General disorders Chest discomfort	1.1% 2/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	12.4% 44/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	2.6% 4/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	11.1% 35/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
General disorders Feeling hot	0.57% 1/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	5.3% 19/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	6.3% 20/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Cardiac disorders Tachycardia	1.1% 2/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	6.7% 24/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	3.2% 10/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Cardiac disorders Palpitations	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	5.3% 19/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.66% 1/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	3.5% 11/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Gastrointestinal disorders Nausea	0.57% 1/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	12.1% 43/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	2.0% 3/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	8.5% 27/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 2/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	10.7% 38/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	2.6% 4/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	18.0% 57/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Vascular disorders Flushing	2.3% 4/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	9.8% 35/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	2.0% 3/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	11.7% 37/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Investigations Heart rate increased	0.00% 0/176 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	5.6% 20/356 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	0.00% 0/151 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.	4.7% 15/316 • Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported. Treatment Emergent Adverse Events were defined as Adverse Events starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.

Additional Information

Senior Medical Director, Medical Affairs

Astellas Pharma Global Development

Email: clinicaltrials@us.astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
• Publication restrictions are in place

Restriction type: OTHER