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

Astellas

Status and phase: Completed; Phase 4

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

Treatments: Drug: Regadenoson; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862641

3606-CL-3001

Details and patient eligibility

About

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

Enrollment: 1,009 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,009 participants in 4 patient groups, including a placebo group

Placebo - Asthma

Placebo Comparator group

Description:

Matching intravenous (IV) bolus injection, subjects with Asthma

Treatment:

Drug: Placebo

Regadenoson - Asthma

Experimental group

Description:

0.4mg / 5mL intravenous bolus injection, subjects with Asthma

Treatment:

Drug: Regadenoson

Placebo - COPD

Placebo Comparator group

Description:

Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

Treatment:

Drug: Placebo

Regadenoson - COPD

Experimental group

Description:

0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

Treatment:

Drug: Regadenoson