Phase 4
Completed N=1,009
A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease
Asthma · Coronary Artery Disease · Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00862641 ↗
Enrolled (actual)
1,009
Serious AEs
0.6%
Results posted
Dec 2010
Primary outcomePrimary: Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment — 2.9; 1.1; 5.4; 4.2 Percentage of Subjects — p=0.1451
Summary
This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment |
2.9; 1.1; 5.4; 4.2 | 0.1451 |
| SECONDARY Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration |
2; 5; 2; 5 | — |
| SECONDARY Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration |
2; 5; 2; 5 | — |
| SECONDARY Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values |
2.41; 2.35; 1.70; 1.70; 2.37; 2.33 | 0.0029 sig |
| SECONDARY Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted |
81.34; 80.32; 55.67; 55.69; 79.91; 80.11 | 0.0015 sig |
| SECONDARY Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC) |
3.22; 3.16; 2.75; 2.83; 3.17; 3.11 | 0.0789 |
| SECONDARY Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio |
74.88; 74.59; 61.95; 60.00; 75.11; 75.09 | 0.2087 |
| SECONDARY Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry |
96.3; 96.3; 94.7; 95.0; 95.9; 96.0 | 0.9904 |
| SECONDARY Percentage of Selected Respiratory Adverse Events |
1.1; 10.7; 2.6; 18.0; 1.1; 3.1 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00862641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.