A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease
NCT ID: NCT00862641
Last Updated: 2012-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1009 participants
INTERVENTIONAL
2009-04-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Placebo - Asthma
Matching intravenous (IV) bolus injection, subjects with Asthma
Placebo
IV
Regadenoson - Asthma
0.4mg / 5mL intravenous bolus injection, subjects with Asthma
Regadenoson
IV
Placebo - COPD
Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Placebo
IV
Regadenoson - COPD
0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Regadenoson
IV
Interventions
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Regadenoson
IV
Placebo
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Auburn, Maine, United States
No. Dartmouth, Massachusetts, United States
Minneapolis, Minnesota, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
Papillion, Nebraska, United States
Brick, New Jersey, United States
Raleigh, North Carolina, United States
Chardon, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Upland, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Easley, South Carolina, United States
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
New Braunfels, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Montgomery, Alabama, United States
Anaheim, California, United States
Encinitas, California, United States
Fullerton, California, United States
Huntington Beach, California, United States
Long Beach, California, United States
Mission Viejo, California, United States
Roseville, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Waterbury, Connecticut, United States
Newark, Delaware, United States
Wilmington, Delaware, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Miami, Florida, United States
Trinity, Florida, United States
Winter Park, Florida, United States
Stockbridge, Georgia, United States
Aurora, Illinois, United States
Topeka, Kansas, United States
Shreveport, Louisiana, United States
Countries
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References
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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.
Related Links
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Link to Prescribing information
Other Identifiers
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3606-CL-3001
Identifier Type: -
Identifier Source: org_study_id