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To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.
This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. 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 |
|---|---|---|---|
| 15 mcg BID / 30 mcg QD | Experimental | Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit. |
|
| 30 mcg QD / 15 mcg BID | Experimental | Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arformoterol Tartrate Inhalation Solution | Drug | Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing. | 0-24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing. | 0-12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pulmonary Medical Director | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medford | Oregon | 97504 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19808130 | Derived | Panettieri RA Jr, MacIntyre N, Sims M, Kerwin E, Fogarty C, Noonan M, Claus R, Andrews WT. Comparison of the efficacy and safety of arformoterol 15 microg twice daily and arformoterol 30 microg once daily in COPD: a single-dose, multicenter, randomized, modified-blind, two-way crossover study. Clin Ther. 2009 Aug;31(8):1716-23. doi: 10.1016/j.clinthera.2009.08.012. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 15 Mcg BID / 30 Mcg QD | Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit. |
| FG001 | 30 Mcg QD / 15 Mcg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Arformoterol Tartrate Inhalation Solution | Drug | Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD) |
|
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| Placebo | Drug | Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day |
|
| Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing. | 12-24 hours |
| Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level. | pre-dose and 24 hours post-dose |
| Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose. | pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose |
| Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose. | Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose |
| Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose | Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points. | Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose |
| Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose | Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value. | Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose |
| Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose. | Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing. | 12 hours |
| Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time. | 12 hours |
| Time to Onset of 15 Percent Response Within 12 Hours of Dosing | Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included. | 12 hours post first dose |
| Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing | Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included | up to 12 hours post dose |
| Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing | Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. | pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose |
| Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point | Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point. | immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose |
| Portland |
| Oregon |
| 97213 |
| United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Spartanburg | South Carolina | 29303 | United States |
Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 15 Mcg BID / 30 Mcg QD | Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit. |
| BG001 | 30 Mcg QD / 15 Mcg BID | Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Inhaled Corticosteroid Use at Baseline | This measure answers the question: Does the patient use a corticosteroid inhaler at the baseline visit? | Number | participants |
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| Participants Categorized by the Number of Pack Years Smoked | Pack years smoked is a way to measure the amount a person has smoked over a long period of time. It is calculated by taking the number of cigarettes smoked per day times the the number of years smoked divided by 20 (cigarettes per pack). | Number | participants |
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| Participants Categorized by the Number of Packs Currently Smoked per Day | This measure gives an indication of the quantity of cigarettes currently smoked per day. | Number | participants |
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| 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 | Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing. | Intent to treat population | Posted | Mean | Standard Deviation | liters | 0-24 hours post dose |
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| Secondary | Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing. | Intent to treat population | Posted | Mean | Standard Deviation | liters | 0-12 hours |
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| Secondary | Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing. | Intent to treat population | Posted | Mean | Standard Deviation | liters | 12-24 hours |
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| Secondary | Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level. | Intent to treat population | Posted | Mean | Standard Deviation | liters | pre-dose and 24 hours post-dose |
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| Secondary | Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose. | Intent to treat population | Posted | Mean | Standard Deviation | liters | pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose |
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| Secondary | Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose. | Intent to treat population | Posted | Mean | Standard Deviation | liters | Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose |
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| Secondary | Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose | Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points. | Intent to treat population | Posted | Mean | Standard Deviation | Percent of Predicted FEV1 | Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose |
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| Secondary | Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose | Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value. | Intent to treat population | Posted | Mean | Standard Deviation | percent of predicted FEV1 | Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose |
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| Secondary | Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose. | Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing. | Intent to treat population | Posted | Mean | Standard Deviation | percent of predicted FEV1 | 12 hours |
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| Secondary | Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time. | Posted | Mean | Standard Deviation | liters | 12 hours |
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| Secondary | Time to Onset of 15 Percent Response Within 12 Hours of Dosing | Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included. | Intent to treat population. Limited to those patients who had a 15% response. | Posted | Median | Full Range | minutes | 12 hours post first dose |
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| Secondary | Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing | Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included | Intent to treat population. Limited to patients who met both criteria: a 12 percent increase in FEV1 and a 200 milliliter increase in FEV1 | Posted | Median | Full Range | minutes | up to 12 hours post dose |
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| Secondary | Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing | Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. | Intent to treat population | Posted | Mean | Standard Deviation | minutes | pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose |
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| Secondary | Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point | Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point. | Intent to treat population | Posted | Mean | Standard Deviation | liters | immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose |
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Total number of participants in study is 33. 33 particpants at risk in each treatment arm due to cross over study design.
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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 | 15 Mcg BID | Arformoterol 15 mcg twice a day (morning and evening) | 0 | 33 | 2 | 33 | ||
| EG001 | 30 Mcg QD | Arformoterol 30 mcg once a day (morning) and placebo (evening) | 0 | 33 | 3 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Arthraglia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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Single day/dose; small numbers of subjects; difference between arms (2mL vs 4mL per dose); Predefined +/-0.07L equivalence is arbitrarily lower than the clinically recognized 0.1L. Hence, clinical efficacy & safety conclusions are difficult to reach.
In addition to the 60 to 180 day restriction above, since this is a multicenter study, first publication of study results shall be made with other participating study sites as a multicenter publication; provided, 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 | |
|---|---|---|---|---|
| Brovana Medical Director | Sunovion | 1-866-503-6351 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D004646 | Emphysema |
| 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 |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No |
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| >=25 years - < 30 years |
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| >=30 years |
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| >1 -2 packs |
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| >2 - 4 packs |
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| > 4 packs |
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| Currently does not smoke |
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