AsthmaPhase 4NCT00862641

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

A Phase 4 study testing Regadenoson in people with Asthma and Coronary Artery Disease, run by Astellas Pharma Inc at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
What is being tested?: Regadenoson
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,009 participants
Where: 48 sitesUnited States
Study dates: Apr 2009to Oct 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

48 sites in 1 country.

City, postcode or hospital

48 sites in 1 country

United States48 sites

Study site
Anaheim, California, 92801
Study site
Auburn, Maine, 04210
Study site
Aurora, Illinois, 60504
Study site
Brick, New Jersey, 08723
Study site
Chardon, Ohio, 44024
Study site
Charleston, South Carolina, 29407
Study site
Cincinnati, Ohio, 45206
Study site
Cincinnati, Ohio, 45231
Study site
Clearwater, Florida, 33756
Study site
Dallas, Texas, 75231
Study site
DeLand, Florida, 32720
Study site
Easley, South Carolina, 29640
Study site
Encinitas, California, 92024
Study site
Fullerton, California, 92835
Study site
Greenville, South Carolina, 29615
Study site
Houston, Texas, 77074
Study site
Huntington Beach, California, 92647
Study site
Knoxville, Tennessee, 37920
Study site
Long Beach, California, 90806
Study site
Medford, Oregon, 97504
Study site
Miami, Florida, 33173
Study site
Minneapolis, Minnesota, 55402
Study site
Mission Viejo, California, 92691
Study site
Montgomery, Alabama, 36117
Study site
New Braunfels, Texas, 78130
Study site
Newark, Delaware, 19713
Study site
No. Dartmouth, Massachusetts, 02747
Study site
Oklahoma City, Oklahoma, 73103
Study site
Papillion, Nebraska, 68046
Study site
Plymouth, Minnesota, 55441
Study site
Providence, Rhode Island, 02906
Study site
Raleigh, North Carolina, 27607
Study site
Roseville, California, 95661
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92120
Study site
San Diego, California, 92123
Study site
Santa Ana, California, 92704
Study site
Seattle, Washington, 98105
Study site
Shreveport, Louisiana, 71104
Study site
Spartanburg, South Carolina, 29303
Study site
St Louis, Missouri, 63141
Study site
Stockbridge, Georgia, 30281
Study site
Topeka, Kansas, 66606
Study site
Trinity, Florida, 34655
Study site
Upland, Pennsylvania, 19013
Study site
Waterbury, Connecticut, 06708
Study site
Wilmington, Delaware, 19807
Study site
Winter Park, Florida, 32789

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About this study

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).

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

Conditions: Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
Being tested: Regadenoson, Placebo
Keywords: regadenoson, CVT 3146, asthma, coronary artery disease, pulmonary disease, chronic obstructive
Medical subject headings: Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RegadenosonDrug
Also called CVT3146, Lexiscan
IV
PlaceboDrug
IV

Study groups in NCT00862641
Study group	Role	What they receive
Placebo - Asthma	Placebo comparator	Matching intravenous (IV) bolus injection, subjects with Asthma Receives: Drug: Placebo
Regadenoson - Asthma	Experimental	0.4mg / 5mL intravenous bolus injection, subjects with Asthma Receives: Drug: Regadenoson
Placebo - COPD	Placebo comparator	Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) Receives: Drug: Placebo
Regadenoson - COPD	Experimental	0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD) Receives: Drug: Regadenoson

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 Hours post dose

Secondary outcomes (8)

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.
Measured: Within 2 Hours of study drug administration
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.
Measured: Within 24 Hours of study drug administration
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.
Measured: Baseline and Hour 2
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.
Measured: Baseline and Hour 2
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.
Measured: Baseline and Hour 2
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.
Measured: Baseline and Hour 2
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.
Measured: Baseline and Hour 2
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.
Measured: Within 24 Hours of study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Oct 2009

First posted17 Mar 2009 (estimated)
Study startApr 2009
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,009 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00862641
Sponsor's protocol ID: 3606-CL-3001
Status last verified: Sep 2012
First submitted: 15 Mar 2009
Last updated: 18 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22484721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT00862641
Acronym / sponsor ID: 3606-CL-3001
Conditions: Asthma, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
Keywords: regadenoson, CVT 3146, asthma, coronary artery disease, pulmonary disease, chronic obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,009 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 17 Mar 2009 (estimated)
Results: Posted 15 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo - Asthma	Placebo comparator	Drug: PlaceboMatching intravenous (IV) bolus injection, subjects with Asthma
Regadenoson - Asthma	Experimental	Drug: Regadenoson0.4mg / 5mL intravenous bolus injection, subjects with Asthma
Placebo - COPD	Placebo comparator	Drug: PlaceboMatching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Regadenoson - COPD	Experimental	Drug: Regadenoson0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RegadenosonAlso: CVT3146, LexiscanIV	Drug	Regadenoson - Asthma, Regadenoson - COPD
PlaceboIV	Drug	Placebo - Asthma, Placebo - COPD

Primary outcome

Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment
Time frame: 2 Hours post dose
FEV1 data was obtained by spirometry measures.

8 secondary outcomes

Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
Time frame: Within 2 Hours of study drug administration
Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration
Time frame: Within 24 Hours of study drug administration
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio
Time frame: Baseline and Hour 2
Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry
Time frame: Baseline and Hour 2
Percentage of Selected Respiratory Adverse Events
Time frame: Within 24 Hours of study drug administration

Results and safety

Results posted to the registry on 15 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo - Asthma	177	176
Regadenoson - Asthma	360	356
Placebo - COPD	152	151
Regadenoson - COPD	320	316

Primary outcome: Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment

Time frame: 2 Hours post dose. Number. Unit: Percentage of Subjects

Measure	Placebo - Asthma n = 176	Regadenoson - Asthma n = 356	Placebo - COPD n = 151	Regadenoson - COPD n = 316
Value	2.9	1.1	5.4	4.2

Placebo - Asthma vs Regadenoson - Asthma: p = 0.1451, Cochran-Mantel-Haenszel
Placebo - COPD vs Regadenoson - COPD: p = 0.5790, Cochran-Mantel-Haenszel

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

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event collection began immediately following study drug administration through the follow-up visit. Serious Adverse Events occurring until 30 days after dosing were reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Asthma	0 of 176 (0%)	40 of 176 (22.7%)	Not reported
Regadenoson - Asthma	2 of 356 (0.6%)	212 of 356 (59.6%)	Not reported
Placebo - COPD	0 of 151 (0%)	30 of 151 (19.9%)	Not reported
Regadenoson - COPD	4 of 316 (1.3%)	177 of 316 (56%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22484721Prenner 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.
Link to Prescribing informationLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Use Central Contact study director

Astellas Pharma Global Development

48 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Regadenoson in people with Asthma and Coronary Artery Disease, run by Astellas Pharma Inc at 48 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment (time frame: 2 Hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00862641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.