A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease
Condition: Asthma; Coronary Artery Disease; Pulmonary Disease, Chronic Obstructive
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Chronic Disease
Intervention: Regadenoson; Placebo
Intervention description: IV; IV
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1009.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: regadenoson; CVT 3146; asthma; coronary artery disease; pulmonary disease, chronic obstructive

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 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.