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

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ClinicalTrials.gov Identifier: NCT00862641
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : December 15, 2010
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

March 15, 2009
March 17, 2009
November 15, 2010
December 15, 2010
September 18, 2012
April 2009
October 2009   (Final data collection date for 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 ]
FEV1 data was obtained by spirometry measures.
Rate of selected respiratory adverse events including bronchospasm, wheezing, dyspnea, respiratory distress and upper airway resistance syndrome, as well as the overall rate of all these adverse events. [ Time Frame: 24 +/- 4 hours post dose ]
Complete list of historical versions of study NCT00862641 on ClinicalTrials.gov Archive Site
  • Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration [ Time Frame: Within 2 Hours of 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.

  • Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration [ Time Frame: Within 24 Hours of 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.

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

    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 ]

    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 ]

    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 ]

    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 ]
    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 ]

    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.

  • Use of short-acting bronchodilators for treatment of symptoms after study drug administration. [ Time Frame: 24 +/- 4 hours post dose ]
  • Change from baseline to the 2 hour post-dose assessment for forced expiratory volume in 1 second (FEV1) absolute values and percent predicted [ Time Frame: 2 hours post dose ]
  • Change from baseline to the 2 hour post-dose assessment for >15% decrease in FEV1 [ Time Frame: 2 hours post dose ]
  • Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) [ Time Frame: 2 hours post dose ]
  • Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio [ Time Frame: 2 hours post dose ]
  • Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry [ Time Frame: 2 hours post dose ]
Not Provided
Not Provided
 
A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
  • Asthma
  • Coronary Artery Disease
  • Pulmonary Disease, Chronic Obstructive
  • Drug: Regadenoson
    IV
    Other Names:
    • CVT3146
    • Lexiscan
  • Drug: Placebo
    IV
  • Placebo Comparator: Placebo - Asthma
    Matching intravenous (IV) bolus injection, subjects with Asthma
    Intervention: Drug: Placebo
  • Experimental: Regadenoson - Asthma
    0.4mg / 5mL intravenous bolus injection, subjects with Asthma
    Intervention: Drug: Regadenoson
  • Placebo Comparator: Placebo - COPD
    Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
    Intervention: Drug: Placebo
  • Experimental: Regadenoson - COPD
    0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
    Intervention: Drug: Regadenoson
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1009
900
October 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00862641
3606-CL-3001
No
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma Global Development
Astellas Pharma Inc
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP