A Study of the Safety and Tolerance of Regadenoson in Sub... | NCT00862641

NCT00862641

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo - Asthma	Placebo Comparator	Matching intravenous (IV) bolus injection, subjects with Asthma	Drug: Placebo
Regadenoson - Asthma	Experimental	0.4mg / 5mL intravenous bolus injection, subjects with Asthma	Drug: Regadenoson
Placebo - COPD	Placebo Comparator	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Drug: Placebo
Regadenoson - COPD	Experimental	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	Drug: Regadenoson

Name	Type	Description	Arm Group Labels	Other Names
Regadenoson	Drug	IV	Regadenoson - Asthma Regadenoson - COPD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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.

Contacts/Locations Module

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Global Development	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Montgomery	Alabama	36117	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22484721	Result	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.

Label	URL
Link to Prescribing information	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
FG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
BG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
BG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
BG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

Between 18 and 64 years

Title	Measurements
	BG000148 BG001304 BG00295 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000115 BG001245 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000128 BG001283 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

Posted

Number

Percentage of Subjects

2 Hours post dose

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

Units	Counts
Participants	OG000176 OG001356 OG002151 OG003

Title

Denominators

Categories

Title	Measurements
	OG0002.9 OG0011.1 OG0025.4 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Analysis of treatment effect was based on the Cochran-Mantel Haenszel(CMH) test stratified by investigative site. Sites with <15 subjects were pooled.	0.1451							95						No	Superiority or Other
OG002 OG003		Cochran-Mantel-Haenszel

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.

The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

Posted

Number

Subjects

Within 2 Hours of study drug administration

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD

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.

The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

Posted

Number

Subjects

Within 24 Hours of study drug administration

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD

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.

The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each time point is noted in the category titles, as "N".

Posted

Mean

Standard Deviation

Liters

Baseline and Hour 2

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

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.

Posted

Mean

Standard Deviation

Percentage of Predicted FEV1

Baseline and Hour 2

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

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.

Posted

Mean

Standard Deviation

Liters

Baseline and Hour 2

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

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.

Posted

Mean

Standard Deviation

Percentage of FEV1 / FVC

Baseline and Hour 2

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

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.

Posted

Mean

Standard Deviation

Percentage of Oxygen Saturation

Baseline and Hour 2

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

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.

The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.

Posted

Number

Percentage of Subjects

Within 24 Hours of study drug administration

ID	Title	Description
OG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma
OG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma
OG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
OG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo - Asthma	Matching intravenous (IV) bolus injection, subjects with Asthma	0	176	40	176
EG001	Regadenoson - Asthma	0.4mg / 5mL intravenous bolus injection, subjects with Asthma	2	356	212	356
EG002	Placebo - COPD	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	0	151	30	151
EG003	Regadenoson - COPD	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)	4	316	177	316

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Atrioventricular block complete	Cardiac disorders	MedDRA (11.1)	Systematic Assessment		EG0000 affected176 at risk EG0011 affected356 at risk EG0020 affected151 at risk EG0030 affected316 at risk
Bradycardia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment		EG0000 affected176 at risk EG0010 affected356 at risk EG0020 affected151 at risk EG003
Electrocardiogram change	Investigations	MedDRA (11.1)	Systematic Assessment		EG0000 affected176 at risk EG0010 affected356 at risk EG0020 affected151 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment		EG0000 affected176 at risk EG0010 affected356 at risk EG0020 affected151 at risk EG003
Rectal hemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	SAE was reported after the follow-up visit.	EG0000 affected176 at risk EG0011 affected356 at risk EG0020 affected151 at risk EG003
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	SAE was reported after the follow-up visit.	EG0000 affected176 at risk EG0010 affected356 at risk EG0020 affected151 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00017 affected176 at risk EG00197 affected356 at risk EG00212 affected151 at risk EG00362 affected316 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0008 affected176 at risk EG00169 affected356 at risk EG0024 affected151 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00013 affected176 at risk EG00133 affected356 at risk EG0026 affected151 at risk EG003
Chest discomfort	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected176 at risk EG00144 affected356 at risk EG0024 affected151 at risk EG003
Feeling hot	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected176 at risk EG00119 affected356 at risk EG0020 affected151 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected176 at risk EG00124 affected356 at risk EG0020 affected151 at risk EG003
Palpitations	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected176 at risk EG00119 affected356 at risk EG0021 affected151 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected176 at risk EG00143 affected356 at risk EG0023 affected151 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected176 at risk EG00138 affected356 at risk EG0024 affected151 at risk EG003
Flushing	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected176 at risk EG00135 affected356 at risk EG0023 affected151 at risk EG003
Heart rate increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 affected176 at risk EG00120 affected356 at risk EG0020 affected151 at risk EG003

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Certain Agreements

ID	Term
D001249	Asthma
D003324	Coronary Artery Disease
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C430916	regadenoson