Phase 3
Completed N=443
Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT00250679 ↗Enrolled (actual)
443
Serious AEs
—
Results posted
Feb 2009
Primary outcomePrimary: Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations — 66.7; 67.8; 76.2; 10.9 percent of participants
Summary
To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations |
66.7; 67.8; 76.2; 10.9; 13.4; 11.6 | — |
| SECONDARY Number of Participants With New 24-Hour Holter Monitoring Alerts |
15; 19; 9 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Glucose Evaluations |
1; 0; 1; 20; 55; 54 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Potassium Evaluations |
2; 4; 3; 4; 1; 1 | — |
| SECONDARY Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts |
1; 1; 5 | — |
| SECONDARY Inspiratory Capacity Changes From Baseline |
0.240; 0.297; 0.330; 0.058; 0.032; 0.124 | — |
| SECONDARY 6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1) |
0.294; 0.314; 0.357; 0.280; 0.305; 0.334 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Heart Rate |
6; 5; 2; 2; 1; 1 | — |
| SECONDARY Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week |
4.10; 3.73; 3.84; 2.66; 2.36; 2.52 | — |
| SECONDARY Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day |
2.70; 2.43; 2.67; 1.61; 1.59; 1.58 | — |
| SECONDARY Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week |
4.18; 4.20; 4.23; 2.85; 2.44; 2.75 | — |
| SECONDARY Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day |
2.91; 2.68; 2.97; 1.71; 1.56; 1.65 | — |
| SECONDARY Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline |
0.191; 0.216; 0.253; 0.175; 0.208; 0.224 | — |
| SECONDARY Transitional (Relative Change in) Dyspnea Index |
1.50; 1.47; 1.56; 1.44; 1.43; 1.49 | — |
| SECONDARY Number of Participants With an Improved Transitional Dyspnea Index |
59; 59; 61; 56; 49; 54 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough) |
0.162; 0.172; 0.155; 0.096; 0.124; 0.131 | — |
| SECONDARY Subject Global Evaluations Change From Baseline |
-0.96; -1.11; -0.89; -0.97; -1.06; -0.83 | — |
| SECONDARY Investigator Global Evaluations Change From Baseline |
-0.66; -0.88; -0.75; -0.74; -0.74; -0.76 | — |
| SECONDARY BODE Index |
4.82; 4.98; 5.14; 4.22; 3.97; 4.28 | — |
| SECONDARY 6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes |
15.28; 15.72; 12.37; 16.05; 4.13; 31.07 | — |
| SECONDARY Mean Change From Baseline in St. George's Respiratory Questionnaire |
-4.16; -3.44; -1.92; -6.76; -3.73; -3.68 | — |
| SECONDARY Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire |
49; 47; 39; 55; 43; 42 | — |
| SECONDARY Modified Medical Research Council Dyspnea Questionaire |
2.73; 2.76; 2.91; 2.33; 2.47; 2.50 | — |
| SECONDARY Percent (%) of Participants With an Improved Transitional Dyspnea Index |
51.3; 52.2; 53.5; 51.9; 48.0; 52.4 | — |
| SECONDARY Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire |
46.7; 46.1; 37.1; 56.7; 45.7; 43.3 | — |
| SECONDARY Mean Values for the 6-Minute Walk Test: Distance Walked in Meters |
334.84; 315.94; 328.36; 352.19; 332.80; 339.81 | — |
| SECONDARY Mean Values for Investigator Global Evaluations |
3.73; 3.88; 3.84; 3.12; 3.04; 3.04 | — |
| SECONDARY Mean Values for St. George's Respiratory Questionnaire |
48.86; 49.36; 52.40; 43.48; 43.64; 49.95 | — |
| SECONDARY Mean Values for Subject Global Evaluations |
3.73; 3.97; 3.86; 2.83; 2.88; 2.94 | — |
| SECONDARY Mean Values for Inspiratory Capacity |
1.739; 1.864; 1.764; 1.826; 1.889; 1.909 | — |
| SECONDARY Mean Values for Forced Expiratory Volume in One Second (FEV1) |
1.210; 1.222; 1.204; 1.378; 1.400; 1.360 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male and female subjects must be at least 35 years old at the time of consent
- Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD
- Subjects must have a >=15 pack-year smoking history and a baseline breathlessness severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visits 1 and 2
- Female subjects 5% of total white blood cell count
- Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1
- Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions)
Data sourced from ClinicalTrials.gov (NCT00250679). 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.