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

Study Overview
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Brief Summary
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This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.

Official Title
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A Phase 4, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD).

Conditions
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Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Regadenoson
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo - Asthma<br>Matching intravenous (IV) bolus injection, subjects with Asthma | Drug: Placebo<br>* IV<br>|
| Experimental: Regadenoson - Asthma<br>0.4mg / 5mL intravenous bolus injection, subjects with Asthma | Drug: Regadenoson<br>* IV<br>* Other names: Lexiscan;|
| Placebo Comparator: Placebo - COPD<br>Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) | Drug: Placebo<br>* IV<br>|
| Experimental: Regadenoson - COPD<br>0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) | Drug: Regadenoson<br>* IV<br>* Other names: Lexiscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 Hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Within 24 Hours of study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regadenoson, CVT 3146, asthma, coronary artery disease, pulmonary disease, chronic obstructive