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

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).

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Pulmonary Disease, Chronic Obstructive; Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Regadenoson

• Study Type: Interventional
• Enrollment (Actual): 1009
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
  • California
    • Anaheim, California, United States, 92801
    • Encinitas, California, United States, 92024
    • Fullerton, California, United States, 92835
    • Huntington Beach, California, United States, 92647
    • Long Beach, California, United States, 90806
    • Mission Viejo, California, United States, 92691
    • Roseville, California, United States, 95661
    • San Diego, California, United States, 92123
    • San Diego, California, United States, 92120
    • Santa Ana, California, United States, 92704
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
  • Delaware
    • Newark, Delaware, United States, 19713
    • Wilmington, Delaware, United States, 19807
  • Florida
    • Clearwater, Florida, United States, 33756
    • Deland, Florida, United States, 32720
    • Miami, Florida, United States, 33173
    • Trinity, Florida, United States, 34655
    • Winter Park, Florida, United States, 32789
  • Georgia
    • Stockbridge, Georgia, United States, 30281
  • Illinois
    • Aurora, Illinois, United States, 60504
  • Kansas
    • Topeka, Kansas, United States, 66606
  • Louisiana
    • Shreveport, Louisiana, United States, 71104
  • Maine
    • Auburn, Maine, United States, 04210
  • Massachusetts
    • No. Dartmouth, Massachusetts, United States, 02747
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
    • Plymouth, Minnesota, United States, 55441
  • Missouri
    • St Louis, Missouri, United States, 63141
    • St. Louis, Missouri, United States, 63141
  • Nebraska
    • Papillion, Nebraska, United States, 68046
  • New Jersey
    • Brick, New Jersey, United States, 08723
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
  • Ohio
    • Chardon, Ohio, United States, 44024
    • Cincinnati, Ohio, United States, 45206
    • Cincinnati, Ohio, United States, 45231
  • Oklahoma
    • Oklahoma, Oklahoma, United States, 73103
  • Oregon
    • Medford, Oregon, United States, 97504
  • Pennsylvania
    • Upland, Pennsylvania, United States, 19013
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
  • South Carolina
    • Charleston, South Carolina, United States, 29407
    • Easley, South Carolina, United States, 29640
    • Greenville, South Carolina, United States, 29615
    • Spartanburg, South Carolina, United States, 29303
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
  • Texas
    • Dallas, Texas, United States, 75231
    • Houston, Texas, United States, 77074
    • New Braunfels, Texas, United States, 78130
    • San Antonio, Texas, United States, 78229
  • Washington
    • Seattle, Washington, United States, 98105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo - Asthma; Matching intravenous (IV) bolus injection, subjects with Asthma	Drug: Placebo; IV
EXPERIMENTAL: Regadenoson - Asthma; 0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Drug: Regadenoson; IV; Other Names: Lexiscan; CVT3146
PLACEBO_COMPARATOR: Placebo - COPD; Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Drug: Placebo; IV
EXPERIMENTAL: Regadenoson - COPD; 0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Drug: Regadenoson; IV; Other Names: Lexiscan; CVT3146

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

General Publications

• Prenner BM, Bukofzer S, Behm S, Feaheny K, McNutt BE. A randomized, double-blind, placebo-controlled study assessing the safety and tolerability of regadenoson in subjects with asthma or chronic obstructive pulmonary disease. J Nucl Cardiol. 2012 Aug;19(4):681-92. doi: 10.1007/s12350-012-9547-4. Epub 2012 Apr 7.

Helpful Links

• Link to Prescribing information

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: March 15, 2009
• First Submitted That Met QC Criteria: March 15, 2009
• First Posted (ESTIMATE): March 17, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 12, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: asthma; coronary artery disease; regadenoson; CVT 3146; pulmonary disease, chronic obstructive
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma; Chronic Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine A2 Receptor Agonists; Regadenoson
• Other Study ID Numbers: 3606-CL-3001