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).
1 other identifier
interventional
1,009
1 country
48
Brief Summary
This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Apr 2009
Shorter than P25 for phase_4 asthma
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
December 15, 2010
CompletedSeptember 18, 2012
September 1, 2012
6 months
March 15, 2009
November 15, 2010
September 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
Within 2 Hours of study drug administration
Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
Within 24 Hours of study drug administration
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values
Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted
Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)
Baseline and Hour 2
- +3 more secondary outcomes
Study Arms (4)
Placebo - Asthma
PLACEBO COMPARATORMatching intravenous (IV) bolus injection, subjects with Asthma
Regadenoson - Asthma
EXPERIMENTAL0.4mg / 5mL intravenous bolus injection, subjects with Asthma
Placebo - COPD
PLACEBO COMPARATORMatching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Regadenoson - COPD
EXPERIMENTAL0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Montgomery, Alabama, 36117, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Encinitas, California, 92024, United States
Unknown Facility
Fullerton, California, 92835, United States
Unknown Facility
Huntington Beach, California, 92647, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Santa Ana, California, 92704, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Newark, Delaware, 19713, United States
Unknown Facility
Wilmington, Delaware, 19807, United States
Unknown Facility
Clearwater, Florida, 33756, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
Trinity, Florida, 34655, United States
Unknown Facility
Winter Park, Florida, 32789, United States
Unknown Facility
Stockbridge, Georgia, 30281, United States
Unknown Facility
Aurora, Illinois, 60504, United States
Unknown Facility
Topeka, Kansas, 66606, United States
Unknown Facility
Shreveport, Louisiana, 71104, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
No. Dartmouth, Massachusetts, 02747, United States
Unknown Facility
Minneapolis, Minnesota, 55402, United States
Unknown Facility
Plymouth, Minnesota, 55441, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Papillion, Nebraska, 68046, United States
Unknown Facility
Brick, New Jersey, 08723, United States
Unknown Facility
Raleigh, North Carolina, 27607, United States
Unknown Facility
Chardon, Ohio, 44024, United States
Unknown Facility
Cincinnati, Ohio, 45206, United States
Unknown Facility
Cincinnati, Ohio, 45231, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Upland, Pennsylvania, 19013, United States
Unknown Facility
Providence, Rhode Island, 02906, United States
Unknown Facility
Charleston, South Carolina, 29407, United States
Unknown Facility
Easley, South Carolina, 29640, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
New Braunfels, Texas, 78130, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 22484721RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Senior Medical Director, Medical Affairs
- Organization
- Astellas Pharma Global Development
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2009
First Posted
March 17, 2009
Study Start
April 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
September 18, 2012
Results First Posted
December 15, 2010
Record last verified: 2012-09