Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease
