Status:
COMPLETED
A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Asthma
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
1009 Patients enrolled
Trial Details
Trial ID
NCT00862641
Start Date
April 1 2009
End Date
October 1 2009
Last Update
September 18 2012
Active Locations (48)
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1
Montgomery, Alabama, United States, 36117
2
Anaheim, California, United States, 92801
3
Encinitas, California, United States, 92024
4
Fullerton, California, United States, 92835