A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive

In brief

This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.

Key facts

Study ID

NCT00862641

Run by

Astellas Pharma Inc

People needed

1009

Starts

2009-04-01

Expected to finish

2009-10-01

Last updated by the study team

2012-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — Encinitas, California, United States
• Study site — Fullerton, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Wilmington, Delaware, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Trinity, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Stockbridge, Georgia, United States
• Study site — Aurora, Illinois, United States
• Study site — Topeka, Kansas, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Auburn, Maine, United States
• Study site — No. Dartmouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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