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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00862641
First received: March 15, 2009
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Asthma
Coronary Artery Disease
Pulmonary Disease, Chronic Obstructive
Drug: Regadenoson
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    FEV1 data was obtained by spirometry measures.


Secondary Outcome Measures:
  • Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration [ Time Frame: Within 2 Hours of study drug administration ] [ Designated as safety issue: Yes ]

    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.


  • Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration [ Time Frame: Within 24 Hours of study drug administration ] [ Designated as safety issue: Yes ]

    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.


  • Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values [ Time Frame: Baseline and Hour 2 ] [ Designated as safety issue: Yes ]

    FEV1 data was obtained by spirometry measurements.

    Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.


  • Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted [ Time Frame: Baseline and Hour 2 ] [ Designated as safety issue: Yes ]

    FEV1 data was obtained by spirometry measurements.

    Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.


  • Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) [ Time Frame: Baseline and Hour 2 ] [ Designated as safety issue: Yes ]

    FVC data was obtained by spirometry measurements.

    Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.


  • Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio [ Time Frame: Baseline and Hour 2 ] [ Designated as safety issue: Yes ]

    FEV1 and FVC data was obtained by spirometry measurements.

    Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.


  • Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry [ Time Frame: Baseline and Hour 2 ] [ Designated as safety issue: Yes ]
    Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.

  • Percentage of Selected Respiratory Adverse Events [ Time Frame: Within 24 Hours of study drug administration ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 1009
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo - Asthma
Matching intravenous (IV) bolus injection, subjects with Asthma
Drug: Placebo
IV
Experimental: Regadenoson - Asthma
0.4mg / 5mL intravenous bolus injection, subjects with Asthma
Drug: Regadenoson
IV
Other Names:
  • CVT3146
  • Lexiscan
Placebo Comparator: Placebo - COPD
Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Drug: Placebo
IV
Experimental: Regadenoson - COPD
0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
Drug: Regadenoson
IV
Other Names:
  • CVT3146
  • Lexiscan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862641

  Show 49 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00862641     History of Changes
Other Study ID Numbers: 3606-CL-3001
Study First Received: March 15, 2009
Results First Received: November 15, 2010
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
regadenoson
CVT 3146
asthma
coronary artery disease
pulmonary disease, chronic obstructive

Additional relevant MeSH terms:
Asthma
Chronic Disease
Coronary Artery Disease
Coronary Disease
Lung Diseases
Lung Diseases, Obstructive
Myocardial Ischemia
Pulmonary Disease, Chronic Obstructive
Arterial Occlusive Diseases
Arteriosclerosis
Bronchial Diseases
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes
Respiratory Hypersensitivity
Respiratory Tract Diseases
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Agonists
Purinergic P1 Receptor Agonists

ClinicalTrials.gov processed this record on November 25, 2014