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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).
This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD. Study participation will be over approximately 6 months. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formoterol 12 ųg 2x/day | Active Comparator |
| |
| Arformoterol 15 ųg 2x/day | Experimental |
| |
| Arformoterol 25 ųg 2x/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arformoterol tartrate inhalation solution | Drug | Arformoterol 15 ųg BID by nebulization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations | Percent of participants with the adverse event specified. SOC = system organ class. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New 24-Hour Holter Monitoring Alerts | New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline. | Visit 6 (week 27) |
| Number of Participants With Potentially Clinically Significant Glucose Evaluations |
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Key Inclusion Criteria:
Key Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sepracor Medical Director | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20214460 | Background | Hanania NA, Donohue JF, Nelson H, Sciarappa K, Goodwin E, Baumgartner RA, Hanrahan JP. The safety and efficacy of arformoterol and formoterol in COPD. COPD. 2010 Feb;7(1):17-31. doi: 10.3109/15412550903499498. |
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Two patients were each issued two randomization numbers; both subjects are included only once in the intent-to-treat (ITT) population. One additional subject was randomized in error and did not receive study drug. This subject is excluded from the ITT population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Formoterol 12 Mcg 2x/Day | |
| FG001 | Arformoterol 15 Mcg 2x/Day | |
| FG002 | Arformoterol 25 Mcg 2x/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Arformoterol 25 ųg BID | Drug | Arformoterol 25 ųg BID by nebulization |
|
|
| Formoterol 12 ųg BID | Drug | Formoterol fumarate 12 ųg BID via aerolizer/DPI |
|
|
| Placebo | Drug | Placebo nebule or placebo aerolizer |
|
Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant. |
| visit 6 (week 27) |
| Number of Participants With Potentially Clinically Significant Potassium Evaluations | Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant. | visit 6 (week 27) |
| Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts | New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline. | visit 6 (week 27) |
| Inspiratory Capacity Changes From Baseline | Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis. | weeks 0,3,13,26 |
| 6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1) | The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit. | weeks 0,3,13,26 |
| Number of Participants With Potentially Clinically Significant Heart Rate | Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm) | visit 6 (week 27) |
| Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week | Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler. | Screening (day-14 to 0) and Treatment (week 0 - 26) |
| Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day | Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication. | Screening (day-14 to 0) and Treatment (week 0 - 26) |
| Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week | Rescue medication usage during the study. MDI stands for metered dose inhaler. | Screening (day-14 to 0) and Treatment (week 0 - 26) |
| Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day | Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication. | Screening (day-14 to 0) and Treatment (week 0 - 26) |
| Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline | Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method. | weeks 0,3,13,26 |
| Transitional (Relative Change in) Dyspnea Index | The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests. | weeks 13, 26 |
| Number of Participants With an Improved Transitional Dyspnea Index | The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement. | weeks 13, 26 |
| Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough) | The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value. | weeks 0,3,13,26 |
| Subject Global Evaluations Change From Baseline | The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study. | weeks 13, 26 |
| Investigator Global Evaluations Change From Baseline | The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study. | weeks 13, 26 |
| BODE Index | The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit. | Baseline (visit 2), weeks 13, 26 |
| 6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes | Mean change from baseline in distance walked (meters) | Post-Dose weeks 0, 13, 26 |
| Mean Change From Baseline in St. George's Respiratory Questionnaire | Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status. | weeks 13, 26 |
| Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire | Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status. | Visit 4 (week 13) , Visit 5 (week 26) |
| Modified Medical Research Council Dyspnea Questionaire | Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score. | Baseline (visit 2), weeks 13, 26 |
| Percent (%) of Participants With an Improved Transitional Dyspnea Index | The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement. | visits 4 (week 13), visit 5 (week 26) |
| Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire | Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status. | visit 4 (week 13), visit 5 (week 26) |
| Mean Values for the 6-Minute Walk Test: Distance Walked in Meters | This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes. | Baseline (Visit 2), week 13, week 26 |
| Mean Values for Investigator Global Evaluations | The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. | Baseline (Visit 2), Weeks 13, 26 |
| Mean Values for St. George's Respiratory Questionnaire | A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status. | Baseline (Visit 2), weeks 13, 26 |
| Mean Values for Subject Global Evaluations | The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. | Baseline (Visit 2), weeks 13, 26 |
| Mean Values for Inspiratory Capacity | Inspiratory capacity is the maximum volume that can be inhaled. | Baseline (Visit 2), Weeks 3, 13, 26 |
| Mean Values for Forced Expiratory Volume in One Second (FEV1) | Forced Expiratory Volume in one second | Baseline (Visit 2), weeks 3, 13, 26 |
| Jasper |
| Alabama |
| United States |
| Mobile | Alabama | United States |
| Little Rock | Arkansas | United States |
| Carmichael | California | United States |
| Fullerton | California | United States |
| Long Beach | California | United States |
| Paramount | California | United States |
| Rancho Mirage | California | United States |
| San Diego | California | United States |
| Walnut Creek | California | United States |
| Denver | Colorado | United States |
| Hartford | Connecticut | United States |
| Bay Pines | Florida | 33744 | United States |
| Brandon | Florida | United States |
| Gainesville | Florida | 32605 | United States |
| Panama City | Florida | United States |
| Tampa | Florida | United States |
| Atlanta | Georgia | 30309 | United States |
| Marietta | Georgia | United States |
| Normal | Illinois | United States |
| Evansville | Indiana | United States |
| Topeka | Kansas | United States |
| East Slidell | Louisiana | United States |
| Lafayette | Louisiana | United States |
| Metairie | Louisiana | United States |
| Sunset | Louisiana | United States |
| Baltimore | Maryland | United States |
| Chester | Maryland | United States |
| Wheaton | Maryland | United States |
| Ann Arbor | Michigan | United States |
| Saint Charles | Missouri | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | United States |
| Albuquerque | New Mexico | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Statesville | North Carolina | 28625 | United States |
| Wilmington | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Lake Oswego | Oregon | United States |
| Medford | Oregon | 97504 | United States |
| Pittsburgh | Pennsylvania | United States |
| Swarthmore | Pennsylvania | United States |
| East Providence | Rhode Island | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Simpsonville | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Union | South Carolina | 29379 | United States |
| Knoxville | Tennessee | United States |
| Houston | Texas | United States |
| Katy | Texas | United States |
| San Antonio | Texas | United States |
| Danville | Virginia | United States |
| Richmond | Virginia | United States |
| Spokane | Washington | United States |
| Tacoma | Washington | United States |
| Morgantown | West Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Formoterol 12 Mcg 2x/Day | |
| BG001 | Arformoterol 15 Mcg 2x/Day | |
| BG002 | Arformoterol 25 Mcg 2x/Day | |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| # Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in 30 days prior to screening | Number of patients with a specified number of COPD exacerbations in the 30 days prior to screening. COPD stands for 'chronic obstructive pulmonary disease' and is a progressive disease that makes it hard to breath. Exacerbations refers to a worsening of the condition. | Number | participants |
| |||||||||||||||
| # Packs Currently Smoked Per Day | Number of participants with a specified range of packs of cigarettes smoked per day. | Number | participants |
| |||||||||||||||
| Number of Pack-Years Smoked | Number of participants with a specified number range of pack years smoked. Number of pack years smoked is defined as the number of cigarette packs smoked per day times the number of years smoked. | Number | participants |
| |||||||||||||||
| Oral or Inhaled Steroid Use | Number of participants taking oral or inhaled corticosteriod at baseline. These were allowed at study entry and for the duration of the study as long as the regimen was stable for at least 14 days prior to entry and throughout the study. | Number | participants |
| |||||||||||||||
| Race/Ethnicity | Number | participants |
| ||||||||||||||||
| Baseline Dyspnea Index | Baseline Dyspnea Index (range 0-12) is defined to be the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each on a 0-4 scale) obtained at visit 2 (baseline). On each scale, a high measurement represents the most impairment to health. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Forced Expiratory Volume (FEV1) | FEV1 stands for 'forced expiratory volume 1 second'. It is the amount of air that you can forcibly blow out in one second, measured in liters | Mean | Standard Deviation | Liter |
| ||||||||||||||
| Percent Predicted Forced Expiratory Volume (FEV1) | FEV1 stands for 'forced expiratory volume 1 second'. It is the amount of air that you can forcibly blow out in one second, measured in liters. FEV1 can be predicted using patients' height and age. This value is the percent of the predicted FEV1. | Mean | Standard Deviation | percent predicted FEV1 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations | Percent of participants with the adverse event specified. SOC = system organ class. | ITT Population | Posted | Number | percent of participants | Six months |
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| Secondary | Number of Participants With New 24-Hour Holter Monitoring Alerts | New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline. | ITT Population | Posted | Number | Participants | Visit 6 (week 27) |
|
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| Secondary | Number of Participants With Potentially Clinically Significant Glucose Evaluations | Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant. | ITT Population | Posted | Number | Participants | visit 6 (week 27) |
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| Secondary | Number of Participants With Potentially Clinically Significant Potassium Evaluations | Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant. | ITT Population | Posted | Number | Participants | visit 6 (week 27) |
|
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| Secondary | Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts | New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline. | ITT Population | Posted | Number | Participants | visit 6 (week 27) |
|
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| Secondary | Inspiratory Capacity Changes From Baseline | Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis. | ITT Population This outcome was added as an amendment after the study was initiated; therefore approximately half of the ITT population had these assessments at baseline. An available cases analysis was performed with no imputation for missing data. | Posted | Mean | 95% Confidence Interval | Liter | weeks 0,3,13,26 |
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| Secondary | 6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1) | The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit. | ITT population. An available cases analysis was performed with no imputation for missing data. | Posted | Mean | 95% Confidence Interval | Liter | weeks 0,3,13,26 |
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| Secondary | Number of Participants With Potentially Clinically Significant Heart Rate | Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm) | Posted | Number | Participants | visit 6 (week 27) |
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| Secondary | Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week | Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler. | ITT Population | Posted | Mean | 95% Confidence Interval | Days Used / Week | Screening (day-14 to 0) and Treatment (week 0 - 26) |
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| Secondary | Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day | Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication. | ITT Population | Posted | Mean | 95% Confidence Interval | Actuations / Day | Screening (day-14 to 0) and Treatment (week 0 - 26) |
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| Secondary | Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week | Rescue medication usage during the study. MDI stands for metered dose inhaler. | ITT Population | Posted | Mean | 95% Confidence Interval | Days Used / Week | Screening (day-14 to 0) and Treatment (week 0 - 26) |
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| Secondary | Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day | Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication. | ITT Population | Posted | Mean | 95% Confidence Interval | Actuations/Day | Screening (day-14 to 0) and Treatment (week 0 - 26) |
|
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| Secondary | Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline | Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method. | ITT Population. Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis. | Posted | Mean | 95% Confidence Interval | Liter | weeks 0,3,13,26 |
|
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| Secondary | Transitional (Relative Change in) Dyspnea Index | The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests. | ITT Population | Posted | Mean | 95% Confidence Interval | units on a scale | weeks 13, 26 |
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| Secondary | Number of Participants With an Improved Transitional Dyspnea Index | The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement. | ITT Population. Visit 4 n=115,113,114 Visit 5 n=108,102,103 | Posted | Number | Participants | weeks 13, 26 |
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| Secondary | Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough) | The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value. | ITT Population | Posted | Mean | 95% Confidence Interval | Liters | weeks 0,3,13,26 |
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| Secondary | Subject Global Evaluations Change From Baseline | The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study. | ITT Population | Posted | Mean | 95% Confidence Interval | units on a scale | weeks 13, 26 |
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| Secondary | Investigator Global Evaluations Change From Baseline | The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study. | ITT Population | Posted | Mean | 95% Confidence Interval | units on a scale | weeks 13, 26 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | BODE Index | The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline (visit 2), weeks 13, 26 |
|
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| Secondary | 6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes | Mean change from baseline in distance walked (meters) | ITT Population | Posted | Mean | 95% Confidence Interval | meters | Post-Dose weeks 0, 13, 26 |
|
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| Secondary | Mean Change From Baseline in St. George's Respiratory Questionnaire | Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status. | ITT Population | Posted | Mean | 95% Confidence Interval | units on a scale | weeks 13, 26 |
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| Secondary | Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire | Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status. | ITT Population | Posted | Number | Participants | Visit 4 (week 13) , Visit 5 (week 26) |
|
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| Secondary | Modified Medical Research Council Dyspnea Questionaire | Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline (visit 2), weeks 13, 26 |
|
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| Secondary | Percent (%) of Participants With an Improved Transitional Dyspnea Index | The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement. | ITT population. Percentages were based on the number of subjects with non-missing data. Visit 4 n=115, 113, 114 Visit 5 n=108, 102, 103 | Posted | Number | percent of participants | visits 4 (week 13), visit 5 (week 26) |
|
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| Secondary | Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire | Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status. | ITT population | Posted | Number | percent of participants | visit 4 (week 13), visit 5 (week 26) |
|
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| Secondary | Mean Values for the 6-Minute Walk Test: Distance Walked in Meters | This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes. | ITT population | Posted | Mean | Standard Deviation | meters | Baseline (Visit 2), week 13, week 26 |
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| Secondary | Mean Values for Investigator Global Evaluations | The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. | ITT population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Visit 2), Weeks 13, 26 |
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| Secondary | Mean Values for St. George's Respiratory Questionnaire | A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status. | ITT population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Visit 2), weeks 13, 26 |
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| Secondary | Mean Values for Subject Global Evaluations | The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline (Visit 2), weeks 13, 26 |
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| Secondary | Mean Values for Inspiratory Capacity | Inspiratory capacity is the maximum volume that can be inhaled. | Posted | Mean | Standard Deviation | Liters | Baseline (Visit 2), Weeks 3, 13, 26 |
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| Secondary | Mean Values for Forced Expiratory Volume in One Second (FEV1) | Forced Expiratory Volume in one second | Posted | Mean | Standard Deviation | Liters | Baseline (Visit 2), weeks 3, 13, 26 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formoterol 12 Mcg 2x/Day | 14 | 96 | |||||
| EG001 | Arformoterol 15 Mcg 2x/Day | 20 | 97 | |||||
| EG002 | Arformoterol 25 Mcg 2x/Day | 10 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Gasteroenteritis viral | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Lung carcinoma, cell type unspecified, Stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dizziness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Headache | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
Please see dropout rate in participant group. Sunovion is unaware of any other limitations or caveats associated with this study.
In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory Medical Director | Sepracor Inc. | 1-866-503-6351 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001991 | Bronchitis |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 1 exacerbation |
|
| 2 exacerbations |
|
| >2 exacerbations |
|
| >0 - <=1 packs per day |
|
| >1 - <=2 packs per day |
|
| >2 - <=4 packs per day |
|
| >4 packs per day |
|
| >= 15 - < 25 pack years smoked |
|
| >= 25 - < 30 pack years smoked |
|
| >= 30 pack years smoked |
|
| No |
|
| Black or African American |
|
| Caucasian |
|
| Hispanic |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Any Potentially Related AE |
|
| Any Beta-Mediated AE |
|
| Any AE w SOC of Cardiac Disorders |
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| Any Serious AE |
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| Any AE Leading to Discontinuation |
|
| Any COPD Exacerbation (Protocol Definition) |
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| Any COPD Exacerbation (Expanded Definition) |
|
| Any Ischaemic AE |
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| Any Arrhythmnic AE |
|
| Any AE w SOC Respiratory, Thoracic, & Mediastinal |
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