Clinical trial NCT00862641: A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease
Official title: A Phase 4, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Coronary Artery Disease
Pulmonary Disease, Chronic Obstructive
Keywords: regadenoson
CVT 3146
asthma
coronary artery disease
pulmonary disease, chronic obstructive
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 1009
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.

Primary outcomes:
measure: Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment
timeFrame: 2 Hours post dose
Secondary outcomes:
measure: Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
timeFrame: Within 2 Hours of study drug administration
measure: Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
timeFrame: Within 24 Hours of study drug administration
measure: Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values
timeFrame: Baseline and Hour 2
measure: Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted
timeFrame: Baseline and Hour 2
measure: Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)
timeFrame: Baseline and Hour 2
measure: Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio
timeFrame: Baseline and Hour 2
measure: Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry
timeFrame: Baseline and Hour 2
measure: Percentage of Selected Respiratory Adverse Events
timeFrame: Within 24 Hours of study drug administration
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Clearwater
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Trinity
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Aurora
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: No. Dartmouth
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Plymouth
country: United States
state: Minnesota
city: St Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Papillion
country: United States
state: Nebraska
city: Brick
country: United States
state: New Jersey
city: Raleigh
country: United States
state: North Carolina
city: Chardon
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Upland
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Easley
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: New Braunfels
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Prenner BM, Bukofzer S, Behm S, Feaheny K, McNutt BE. A randomized, double-blind, placebo-controlled study assessing the safety and tolerability of regadenoson in subjects with asthma or chronic obstructive pulmonary disease. J Nucl Cardiol. 2012 Aug;19(4):681-92. doi: 10.1007/s12350-012-9547-4. Epub 2012 Apr 7.