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

Asthma Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862641
• Other study ID #: 3606-CL-3001
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2009
• Last updated: September 12, 2012
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: September 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1009
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Coronary Artery Disease
• Coronary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Myocardial Ischemia
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Regadenoson
IV
• Placebo
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment	FEV1 data was obtained by spirometry measures.	2 Hours post dose	Yes
Secondary	Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration	The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).; Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.; The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing.	Within 2 Hours of study drug administration	Yes
Secondary	Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration	The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).; Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.; The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing.	Within 24 Hours of study drug administration	Yes
Secondary	Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values	FEV1 data was obtained by spirometry measurements.; Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.	Baseline and Hour 2	Yes
Secondary	Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted	FEV1 data was obtained by spirometry measurements.; Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.	Baseline and Hour 2	Yes
Secondary	Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)	FVC data was obtained by spirometry measurements.; Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.	Baseline and Hour 2	Yes
Secondary	Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio	FEV1 and FVC data was obtained by spirometry measurements.; Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.	Baseline and Hour 2	Yes
Secondary	Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry	Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.	Baseline and Hour 2	Yes
Secondary	Percentage of Selected Respiratory Adverse Events	The selected respiratory Adverse Events are dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea and wheezing.; Subjects may have reported more than one type of Adverse Event.	Within 24 Hours of study drug administration	Yes

External Links

•   Link to Prescribing information