Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
regadenoson, CVT 3146, asthma, coronary artery disease, pulmonary disease, chronic obstructive
Brief summary
This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.
Interventions
DRUGRegadenoson
IV
DRUGPlacebo
IV
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has asthma or stable chronic obstructive pulmonary disease (COPD). * Subject has a diagnosis of coronary artery disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity Body Mass Index (BMI \> 30). * Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration. * Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson. * Subject is able to safely abstain from theophylline for 12 hours prior to the Day 1 visit, as determined by the Investigator * Asthma subject's frequency and severity of symptoms have remained unchanged within 30 days prior to study drug administration * Asthma subject has FEV1 ≥60% predicted * COPD subject has FEV1/FVC \< 0.70
Exclusion criteria
* Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete. * Subject started on a course of corticosteroids, steroid combination with long-acting Beta2-agonist (LABA) (oral or inhaled) or anticholinergic, or has undergone a change in dose of such medications ≤ 30 days prior to study drug administration (subject on a stable dose of such medications for \> 30 days prior to study drug administration is allowed). * Subject started leukotriene antagonists (e.g., montelukast), cromones (e.g., cromolyn sodium) or 5-lipoxygenase antagonists (e.g. zileuton or zyflo) or has undergone a change in dose of medications in these drug classes ≤ 7 days prior to study drug administration (subject on a stable dose of these medications for \> 7 days prior to study drug administration is allowed). * Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker. * Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed). * Subject is allergic or intolerant to aminophylline. * Subject has had a respiratory infection within 2 weeks prior to randomization. * Subject has had surgery within 3 months prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment | 2 Hours post dose | FEV1 data was obtained by spirometry measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Baseline and Hour 2 | FEV1 data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement. |
| Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Baseline and Hour 2 | FEV1 data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement. |
| Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry | Baseline and Hour 2 | Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement. |
| Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | Within 2 Hours of 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. |
| Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Baseline and Hour 2 | FVC data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement. |
| Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Baseline and Hour 2 | FEV1 and FVC data was obtained by spirometry measurements. Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement. |
| Percentage of Selected Respiratory Adverse Events | Within 24 Hours of study drug administration | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo - Asthma Matching intravenous (IV) bolus injection, subjects with Asthma | 176 |
| Regadenoson - Asthma 0.4mg / 5mL intravenous bolus injection, subjects with Asthma | 356 |
| Placebo - COPD Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) | 151 |
| Regadenoson - COPD 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) | 316 |
| Total | 999 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Randomized, but drug not received | 1 | 4 | 1 | 4 |
Baseline characteristics
| Characteristic | Total | Placebo - Asthma | Regadenoson - Asthma | Placebo - COPD | Regadenoson - COPD |
|---|---|---|---|---|---|
| Age, Customized >=65 years | 263 participants | 28 participants | 52 participants | 56 participants | 127 participants |
| Age, Customized Between 18 and 64 years | 736 participants | 148 participants | 304 participants | 95 participants | 189 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 10 Participants | 1 Participants | 6 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 1 Participants | 4 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 141 Participants | 45 Participants | 61 Participants | 13 Participants | 22 Participants |
| Race/Ethnicity, Customized Native Hawaiian - Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 831 Participants | 128 Participants | 283 Participants | 136 Participants | 284 Participants |
| Sex: Female, Male Female | 559 Participants | 115 Participants | 245 Participants | 67 Participants | 132 Participants |
| Sex: Female, Male Male | 440 Participants | 61 Participants | 111 Participants | 84 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 40 / 176 | 212 / 356 | 30 / 151 | 177 / 316 |
| serious Total, serious adverse events | 0 / 176 | 2 / 356 | 0 / 151 | 4 / 316 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Asthma | 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 |
| Regadenoson - Asthma | Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment | 1.1 Percentage of Subjects |
| Placebo - COPD | Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment | 5.4 Percentage of Subjects |
| Regadenoson - COPD | Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment | 4.2 Percentage of Subjects |
p-value: 0.1451Cochran-Mantel-Haenszel
p-value: 0.579Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 0.16 |
| Placebo - Asthma | 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 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Baseline (N=176; 356; 151; 316) | 2.35 Liters | Standard Deviation 0.623 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Change at Hour 2 (N=174; 351; 147; 313) | -0.01 Liters | Standard Deviation 0.129 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Hour 2 (N=174; 351; 147; 313) | 2.33 Liters | Standard Deviation 0.615 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Hour 2 (N=174; 351; 147; 313) | 1.69 Liters | Standard Deviation 0.651 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Baseline (N=176; 356; 151; 316) | 1.70 Liters | Standard Deviation 0.63 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Change at Hour 2 (N=174; 351; 147; 313) | -0.01 Liters | Standard Deviation 0.152 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Baseline (N=176; 356; 151; 316) | 1.70 Liters | Standard Deviation 0.655 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Change at Hour 2 (N=174; 351; 147; 313) | 0.00 Liters | Standard Deviation 0.159 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values | Hour 2 (N=174; 351; 147; 313) | 1.70 Liters | Standard Deviation 0.647 |
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.0029ANCOVA
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.6189ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Asthma | 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 7.51 |
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Baseline (N=176; 356; 151; 316) | 74.59 Percentage of FEV1 / FVC | Standard Deviation 7.084 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Change at Hour 2 (N=174; 351; 147; 313) | 0.52 Percentage of FEV1 / FVC | Standard Deviation 2.562 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Hour 2 ( N=174; 351; 147; 313) | 75.09 Percentage of FEV1 / FVC | Standard Deviation 7.074 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Hour 2 ( N=174; 351; 147; 313) | 62.26 Percentage of FEV1 / FVC | Standard Deviation 12.907 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Baseline (N=176; 356; 151; 316) | 61.95 Percentage of FEV1 / FVC | Standard Deviation 12.684 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Change at Hour 2 (N=174; 351; 147; 313) | 0.31 Percentage of FEV1 / FVC | Standard Deviation 3.177 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Baseline (N=176; 356; 151; 316) | 60.00 Percentage of FEV1 / FVC | Standard Deviation 13.191 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Change at Hour 2 (N=174; 351; 147; 313) | -0.30 Percentage of FEV1 / FVC | Standard Deviation 3.571 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio | Hour 2 ( N=174; 351; 147; 313) | 59.72 Percentage of FEV1 / FVC | Standard Deviation 13.171 |
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.2087ANCOVA
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.0289ANCOVA
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Baseline (N=176; 356; 151; 316) | 80.32 Percentage of Predicted FEV1 | Standard Deviation 12.99 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Change at Hour 2 (N=174; 351; 147; 313) | -0.17 Percentage of Predicted FEV1 | Standard Deviation 4.519 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Hour 2 (N=174; 351; 147; 313) | 80.11 Percentage of Predicted FEV1 | Standard Deviation 13.324 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Hour 2 (N=174; 351; 147; 313) | 54.89 Percentage of Predicted FEV1 | Standard Deviation 15.601 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Baseline (N=176; 356; 151; 316) | 55.67 Percentage of Predicted FEV1 | Standard Deviation 15.131 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Change at Hour 2 (N=174; 351; 147; 313) | -0.56 Percentage of Predicted FEV1 | Standard Deviation 4.846 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Baseline (N=176; 356; 151; 316) | 55.69 Percentage of Predicted FEV1 | Standard Deviation 16.775 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Change at Hour 2 (N=174; 351; 147; 313) | -0.06 Percentage of Predicted FEV1 | Standard Deviation 5.17 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted | Hour 2 (N=174; 351; 147; 313) | 55.61 Percentage of Predicted FEV1 | Standard Deviation 16.843 |
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.0015ANCOVA
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.4385ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Hour 2 (N=174; 351; 147; 313) | 3.11 Liters | Standard Deviation 0.809 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Baseline (N=176; 356; 151; 316) | 3.16 Liters | Standard Deviation 0.829 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Change at Hour 2 (N=174; 351; 147; 313) | -0.03 Liters | Standard Deviation 0.168 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Change at Hour 2 (N=174; 351; 147; 313) | -0.04 Liters | Standard Deviation 0.23 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Baseline (N=176; 356; 151; 316) | 2.75 Liters | Standard Deviation 0.833 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Hour 2 (N=174; 351; 147; 313) | 2.70 Liters | Standard Deviation 0.856 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Hour 2 (N=174; 351; 147; 313) | 2.84 Liters | Standard Deviation 0.857 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Baseline (N=176; 356; 151; 316) | 2.83 Liters | Standard Deviation 0.889 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) | Change at Hour 2 (N=174; 351; 147; 313) | 0.00 Liters | Standard Deviation 0.239 |
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.0789ANCOVA
Comparison: P-value applies to 'Change at Hour 2'p-value: 0.0258ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 |
| Placebo - Asthma | 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 1.8 |
| Regadenoson - Asthma | 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 |
| Regadenoson - Asthma | 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 1.35 |
| Regadenoson - Asthma | Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry | Hour 2 (N=170; 349; 143; 299) | 96.0 Percentage of Oxygen Saturation | Standard Deviation 1.78 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry | Hour 2 (N=170; 349; 143; 299) | 94.2 Percentage of Oxygen Saturation | Standard Deviation 2.25 |
| Placebo - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry | Baseline (N=170; 350; 143; 302) | 94.7 Percentage of Oxygen Saturation | Standard Deviation 2.4 |
| Placebo - COPD | 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 1.42 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry | Baseline (N=170; 350; 143; 302) | 95.0 Percentage of Oxygen Saturation | Standard Deviation 2.45 |
| Regadenoson - COPD | 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) | -0.5 Percentage of Oxygen Saturation | Standard Deviation 1.66 |
| Regadenoson - COPD | Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry | Hour 2 (N=170; 349; 143; 299) | 94.5 Percentage of Oxygen Saturation | Standard Deviation 2.18 |
Comparison: P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model.p-value: 0.9904ANCOVA
Comparison: P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model.p-value: 0.8085ANCOVA
Secondary
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Asthma | Percentage of Selected Respiratory Adverse Events | Tachypnoea | 0 Percentage of Subjects |
| Placebo - Asthma | Percentage of Selected Respiratory Adverse Events | Dyspnoea | 1.1 Percentage of Subjects |
| Placebo - Asthma | Percentage of Selected Respiratory Adverse Events | Obstructive Airways Disorder | 0 Percentage of Subjects |
| Placebo - Asthma | Percentage of Selected Respiratory Adverse Events | Wheezing | 1.1 Percentage of Subjects |
| Placebo - Asthma | Percentage of Selected Respiratory Adverse Events | Dyspnoea Exertional | 0 Percentage of Subjects |
| Regadenoson - Asthma | Percentage of Selected Respiratory Adverse Events | Obstructive Airways Disorder | 0.3 Percentage of Subjects |
| Regadenoson - Asthma | Percentage of Selected Respiratory Adverse Events | Dyspnoea Exertional | 0 Percentage of Subjects |
| Regadenoson - Asthma | Percentage of Selected Respiratory Adverse Events | Wheezing | 3.1 Percentage of Subjects |
| Regadenoson - Asthma | Percentage of Selected Respiratory Adverse Events | Tachypnoea | 0 Percentage of Subjects |
| Regadenoson - Asthma | Percentage of Selected Respiratory Adverse Events | Dyspnoea | 10.7 Percentage of Subjects |
| Placebo - COPD | Percentage of Selected Respiratory Adverse Events | Dyspnoea Exertional | 0.7 Percentage of Subjects |
| Placebo - COPD | Percentage of Selected Respiratory Adverse Events | Dyspnoea | 2.6 Percentage of Subjects |
| Placebo - COPD | Percentage of Selected Respiratory Adverse Events | Obstructive Airways Disorder | 0 Percentage of Subjects |
| Placebo - COPD | Percentage of Selected Respiratory Adverse Events | Wheezing | 0.7 Percentage of Subjects |
| Placebo - COPD | Percentage of Selected Respiratory Adverse Events | Tachypnoea | 0 Percentage of Subjects |
| Regadenoson - COPD | Percentage of Selected Respiratory Adverse Events | Obstructive Airways Disorder | 0 Percentage of Subjects |
| Regadenoson - COPD | Percentage of Selected Respiratory Adverse Events | Dyspnoea | 18.0 Percentage of Subjects |
| Regadenoson - COPD | Percentage of Selected Respiratory Adverse Events | Wheezing | 0.9 Percentage of Subjects |
| Regadenoson - COPD | Percentage of Selected Respiratory Adverse Events | Dyspnoea Exertional | 0 Percentage of Subjects |
| Regadenoson - COPD | Percentage of Selected Respiratory Adverse Events | Tachypnoea | 0.3 Percentage of Subjects |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Asthma | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 2 Subjects |
| Regadenoson - Asthma | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 5 Subjects |
| Placebo - COPD | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 2 Subjects |
| Regadenoson - COPD | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 5 Subjects |
Secondary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Asthma | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 1 Subjects |
| Regadenoson - Asthma | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 1 Subjects |
| Placebo - COPD | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 2 Subjects |
| Regadenoson - COPD | Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration | 2 Subjects |