Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

Multicenter, Double-Blind, Double-Dummy, Randomized, Active-Controlled, Parallel Group Long-Term Safety Study of 15 μg and 25 μg Arformoterol Tartrate Inhalation Solution BID in Subjects With Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00250679

Enrollment

443

Registered

2005-11-08

Start date

2005-10-31

Completion date

2007-10-31

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Chronic Obstructive Pulmonary Disease, Emphysema

Keywords

COPD, chronic bronchitis, emphysema

Brief 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).

Detailed description

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.

Interventions

DRUGArformoterol tartrate inhalation solution

Arformoterol 15 ųg BID by nebulization

DRUGArformoterol 25 ųg BID

Arformoterol 25 ųg BID by nebulization

DRUGFormoterol 12 ųg BID

Formoterol fumarate 12 ųg BID via aerolizer/DPI

DRUGPlacebo

Placebo nebule or placebo aerolizer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

Inclusion 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 \<=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control * Subjects must be in general good health. Key

Exclusion criteria

* Subjects with a history of asthma, with the exception of asthma diagnosed in childhood * Subjects with a blood eosinophil count \>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)

Design outcomes

Primary

Measure	Time frame	Description
Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Six months	Percent of participants with the adverse event specified. SOC = system organ class.

Secondary

Measure	Time frame	Description
Number of Participants With Potentially Clinically Significant Glucose Evaluations	visit 6 (week 27)	Patients with glucose values that met low (\<=40 mg/dL) or high (\>=175 mg/dL) criteria were considered potentially clinically significant.
Number of Participants With Potentially Clinically Significant Potassium Evaluations	visit 6 (week 27)	Patients with potassium values that met low (\<=3 mEq/L) or high (\>=6 mEq/L) criteria were considered potentially clinically significant.
Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts	visit 6 (week 27)	New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline.
Inspiratory Capacity Changes From Baseline	weeks 0,3,13,26	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.
6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	weeks 0,3,13,26	The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit.
Number of Participants With Potentially Clinically Significant Heart Rate	visit 6 (week 27)	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)
Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening (day-14 to 0) and Treatment (week 0 - 26)	Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler.
Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening (day-14 to 0) and Treatment (week 0 - 26)	Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.
Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening (day-14 to 0) and Treatment (week 0 - 26)	Rescue medication usage during the study. MDI stands for metered dose inhaler.
Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening (day-14 to 0) and Treatment (week 0 - 26)	Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.
Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	weeks 0,3,13,26	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.
Transitional (Relative Change in) Dyspnea Index	weeks 13, 26	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.
Number of Participants With an Improved Transitional Dyspnea Index	weeks 13, 26	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.
Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	weeks 0,3,13,26	The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value.
Number of Participants With New 24-Hour Holter Monitoring Alerts	Visit 6 (week 27)	New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline.
Investigator Global Evaluations Change From Baseline	weeks 13, 26	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.
BODE Index	Baseline (visit 2), weeks 13, 26	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.
6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Post-Dose weeks 0, 13, 26	Mean change from baseline in distance walked (meters)
Mean Change From Baseline in St. George's Respiratory Questionnaire	weeks 13, 26	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.
Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire	Visit 4 (week 13) , Visit 5 (week 26)	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.
Modified Medical Research Council Dyspnea Questionaire	Baseline (visit 2), weeks 13, 26	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.
Percent (%) of Participants With an Improved Transitional Dyspnea Index	visits 4 (week 13), visit 5 (week 26)	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.
Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire	visit 4 (week 13), visit 5 (week 26)	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.
Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Baseline (Visit 2), week 13, week 26	This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes.
Mean Values for Investigator Global Evaluations	Baseline (Visit 2), Weeks 13, 26	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.
Mean Values for St. George's Respiratory Questionnaire	Baseline (Visit 2), weeks 13, 26	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.
Mean Values for Subject Global Evaluations	Baseline (Visit 2), weeks 13, 26	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.
Mean Values for Inspiratory Capacity	Baseline (Visit 2), Weeks 3, 13, 26	Inspiratory capacity is the maximum volume that can be inhaled.
Mean Values for Forced Expiratory Volume in One Second (FEV1)	Baseline (Visit 2), weeks 3, 13, 26	Forced Expiratory Volume in one second
Subject Global Evaluations Change From Baseline	weeks 13, 26	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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
Formoterol 12 Mcg 2x/Day	147
Arformoterol 15 Mcg 2x/Day	149
Arformoterol 25 Mcg 2x/Day	147
Total	443

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	12	15	16
Overall Study	Does Not Meet Entry Criteria	1	4	2
Overall Study	Lack of Efficacy	0	1	3
Overall Study	Lost to Follow-up	3	4	2
Overall Study	Moved	1	1	0
Overall Study	Non-compliance	1	1	0
Overall Study	Protocol Violation	2	4	3
Overall Study	Technical Holter issues	1	0	2
Overall Study	various single events: hip surgery,diary	3	1	1
Overall Study	Withdrawal by Subject	15	18	15

Baseline characteristics

Characteristic	Formoterol 12 Mcg 2x/Day	Arformoterol 15 Mcg 2x/Day	Arformoterol 25 Mcg 2x/Day	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	70 Participants	78 Participants	70 Participants	218 Participants
Age, Categorical Between 18 and 65 years	77 Participants	71 Participants	77 Participants	225 Participants
Age Continuous	63.9 years STANDARD_DEVIATION 7.8	65.4 years STANDARD_DEVIATION 9	63.8 years STANDARD_DEVIATION 8.6	64.4 years STANDARD_DEVIATION 8.5
Baseline Dyspnea Index	5.34 units on a scale STANDARD_DEVIATION 1.72	5.34 units on a scale STANDARD_DEVIATION 2.18	5.10 units on a scale STANDARD_DEVIATION 2.38	5.26 units on a scale STANDARD_DEVIATION 2.09
# Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in 30 days prior to screening 0 exacerbations	146 participants	147 participants	145 participants	438 participants
# Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in 30 days prior to screening 1 exacerbation	1 participants	2 participants	1 participants	4 participants
# Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in 30 days prior to screening >2 exacerbations	0 participants	0 participants	1 participants	1 participants
# Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in 30 days prior to screening 2 exacerbations	0 participants	0 participants	0 participants	0 participants
Forced Expiratory Volume (FEV1)	1.210 Liter STANDARD_DEVIATION 0.42	1.222 Liter STANDARD_DEVIATION 0.465	1.204 Liter STANDARD_DEVIATION 0.422	1.212 Liter STANDARD_DEVIATION 0.435
Number of Pack-Years Smoked >= 15 - < 25 pack years smoked	8 participants	13 participants	13 participants	34 participants
Number of Pack-Years Smoked < 15 pack years smoked	0 participants	0 participants	0 participants	0 participants
Number of Pack-Years Smoked >= 25 - < 30 pack years smoked	10 participants	10 participants	11 participants	31 participants
Number of Pack-Years Smoked >= 30 pack years smoked	129 participants	126 participants	123 participants	378 participants
Oral or Inhaled Steroid Use No	95 participants	90 participants	88 participants	273 participants
Oral or Inhaled Steroid Use Yes	52 participants	59 participants	59 participants	170 participants
# Packs Currently Smoked Per Day >0 - <=1 packs per day	59 participants	38 participants	44 participants	141 participants
# Packs Currently Smoked Per Day 0 packs per day	72 participants	89 participants	82 participants	243 participants
# Packs Currently Smoked Per Day >1 - <=2 packs per day	14 participants	21 participants	17 participants	52 participants
# Packs Currently Smoked Per Day >2 - <=4 packs per day	2 participants	1 participants	4 participants	7 participants
# Packs Currently Smoked Per Day >4 packs per day	0 participants	0 participants	0 participants	0 participants
Percent Predicted Forced Expiratory Volume (FEV1)	41.19 percent predicted FEV1 STANDARD_DEVIATION 11.52	40.87 percent predicted FEV1 STANDARD_DEVIATION 13.59	40.22 percent predicted FEV1 STANDARD_DEVIATION 12.22	40.76 percent predicted FEV1 STANDARD_DEVIATION 12.46
Race/Ethnicity Asian	0 participants	0 participants	0 participants	0 participants
Race/Ethnicity Black or African American	19 participants	21 participants	23 participants	63 participants
Race/Ethnicity Caucasian	127 participants	126 participants	122 participants	375 participants
Race/Ethnicity Hispanic	1 participants	1 participants	2 participants	4 participants
Race/Ethnicity Other	0 participants	1 participants	0 participants	1 participants
Region of Enrollment United States	147 participants	149 participants	147 participants	443 participants
Sex: Female, Male Female	64 Participants	52 Participants	56 Participants	172 Participants
Sex: Female, Male Male	83 Participants	97 Participants	91 Participants	271 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	96 / —	97 / —	109 / —
serious Total, serious adverse events	14 / —	20 / —	10 / —

Outcome results

Primary

Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations

Percent of participants with the adverse event specified. SOC = system organ class.

Time frame: Six months

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE	66.7 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Severe AE	10.9 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Potentially Related AE	34.7 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Beta-Mediated AE	17.0 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE w SOC of Cardiac Disorders	6.1 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Serious AE	9.5 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE Leading to Discontinuation	8.2 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any COPD Exacerbation (Protocol Definition)	22.4 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any COPD Exacerbation (Expanded Definition)	27.9 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Ischaemic AE	1.4 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Arrhythmnic AE	3.4 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE w SOC Respiratory, Thoracic, & Mediastinal	27.2 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE w SOC Respiratory, Thoracic, & Mediastinal	34.2 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE	67.8 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE Leading to Discontinuation	10.1 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any COPD Exacerbation (Expanded Definition)	35.6 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Severe AE	13.4 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Serious AE	13.4 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Arrhythmnic AE	3.4 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Potentially Related AE	32.9 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any COPD Exacerbation (Protocol Definition)	32.2 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE w SOC of Cardiac Disorders	6.0 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Beta-Mediated AE	10.7 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Ischaemic AE	0.7 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Beta-Mediated AE	15.6 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE w SOC of Cardiac Disorders	6.1 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Ischaemic AE	5.4 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Serious AE	6.8 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE Leading to Discontinuation	12.2 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any COPD Exacerbation (Protocol Definition)	30.6 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Arrhythmnic AE	1.4 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE	76.2 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Severe AE	11.6 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any COPD Exacerbation (Expanded Definition)	38.1 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any Potentially Related AE	34.7 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations	Any AE w SOC Respiratory, Thoracic, & Mediastinal	34.0 percent of participants

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.

Time frame: weeks 0,3,13,26

Population: ITT population. An available cases analysis was performed with no imputation for missing data.

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 2 (week 0) n=147,149,147	0.294 Liter	95% Confidence Interval 0.21
Formoterol 12 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 3 (week 3) n=133,133,131	0.280 Liter	95% Confidence Interval 0.229
Formoterol 12 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 4 (week 13) n=117,112,111	0.251 Liter	95% Confidence Interval 0.223
Formoterol 12 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 5 (week 26) n=108,100,103	0.264 Liter	95% Confidence Interval 0.23
Arformoterol 15 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 5 (week 26) n=108,100,103	0.302 Liter	95% Confidence Interval 0.239
Arformoterol 15 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 2 (week 0) n=147,149,147	0.314 Liter	95% Confidence Interval 0.189
Arformoterol 15 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 4 (week 13) n=117,112,111	0.316 Liter	95% Confidence Interval 0.236
Arformoterol 15 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 3 (week 3) n=133,133,131	0.305 Liter	95% Confidence Interval 0.211
Arformoterol 25 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 5 (week 26) n=108,100,103	0.343 Liter	95% Confidence Interval 0.224
Arformoterol 25 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 3 (week 3) n=133,133,131	0.334 Liter	95% Confidence Interval 0.23
Arformoterol 25 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 4 (week 13) n=117,112,111	0.323 Liter	95% Confidence Interval 0.222
Arformoterol 25 Mcg 2x/Day	6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)	Visit 2 (week 0) n=147,149,147	0.357 Liter	95% Confidence Interval 0.218

Secondary

6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes

Mean change from baseline in distance walked (meters)

Time frame: Post-Dose weeks 0, 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 4 (week 13 - post dose) n=116,110,112	16.05 meters	95% Confidence Interval 104.9
Formoterol 12 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 2 (week 0 - post dose) n=146,148,146	15.28 meters	95% Confidence Interval 81.22
Formoterol 12 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 5 (week 26 - post dose) n=106,97,103	24.42 meters	95% Confidence Interval 94.19
Arformoterol 15 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 4 (week 13 - post dose) n=116,110,112	4.13 meters	95% Confidence Interval 128.01
Arformoterol 15 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 2 (week 0 - post dose) n=146,148,146	15.72 meters	95% Confidence Interval 67.59
Arformoterol 15 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 5 (week 26 - post dose) n=106,97,103	1.24 meters	95% Confidence Interval 135.05
Arformoterol 25 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 2 (week 0 - post dose) n=146,148,146	12.37 meters	95% Confidence Interval 69.65
Arformoterol 25 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 5 (week 26 - post dose) n=106,97,103	37.00 meters	95% Confidence Interval 85.01
Arformoterol 25 Mcg 2x/Day	6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes	Visit 4 (week 13 - post dose) n=116,110,112	31.07 meters	95% Confidence Interval 77.2

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.

Time frame: Baseline (visit 2), weeks 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	BODE Index	Visit 5 (week 26) n=103,100,101	3.92 units on a scale	Standard Deviation 1.91
Formoterol 12 Mcg 2x/Day	BODE Index	Visit 2 (baseline- week 0) n=146,148,147	4.82 units on a scale	Standard Deviation 1.58
Formoterol 12 Mcg 2x/Day	BODE Index	Visit 4 (week 13) n=110,108,109	4.22 units on a scale	Standard Deviation 2.03
Arformoterol 15 Mcg 2x/Day	BODE Index	Visit 2 (baseline- week 0) n=146,148,147	4.98 units on a scale	Standard Deviation 1.64
Arformoterol 15 Mcg 2x/Day	BODE Index	Visit 4 (week 13) n=110,108,109	3.97 units on a scale	Standard Deviation 1.9
Arformoterol 15 Mcg 2x/Day	BODE Index	Visit 5 (week 26) n=103,100,101	3.94 units on a scale	Standard Deviation 1.99
Arformoterol 25 Mcg 2x/Day	BODE Index	Visit 4 (week 13) n=110,108,109	4.28 units on a scale	Standard Deviation 1.95
Arformoterol 25 Mcg 2x/Day	BODE Index	Visit 2 (baseline- week 0) n=146,148,147	5.14 units on a scale	Standard Deviation 1.73
Arformoterol 25 Mcg 2x/Day	BODE Index	Visit 5 (week 26) n=103,100,101	4.11 units on a scale	Standard Deviation 2.2

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.

Time frame: weeks 0,3,13,26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 5 (week 26) n=105,97,101	0.087 Liters	95% Confidence Interval 0.215
Formoterol 12 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 3 (week 3) n=130,130,127	0.096 Liters	95% Confidence Interval 0.192
Formoterol 12 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 2 (week 0) n=141,143,141	0.162 Liters	95% Confidence Interval 0.209
Formoterol 12 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 4 (week 13) n=111,108,110	0.094 Liters	95% Confidence Interval 0.192
Arformoterol 15 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 5 (week 26) n=105,97,101	0.098 Liters	95% Confidence Interval 0.243
Arformoterol 15 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 4 (week 13) n=111,108,110	0.116 Liters	95% Confidence Interval 0.187
Arformoterol 15 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 3 (week 3) n=130,130,127	0.124 Liters	95% Confidence Interval 0.209
Arformoterol 15 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 2 (week 0) n=141,143,141	0.172 Liters	95% Confidence Interval 0.206
Arformoterol 25 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 4 (week 13) n=111,108,110	0.101 Liters	95% Confidence Interval 0.207
Arformoterol 25 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 3 (week 3) n=130,130,127	0.131 Liters	95% Confidence Interval 0.201
Arformoterol 25 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 2 (week 0) n=141,143,141	0.155 Liters	95% Confidence Interval 0.226
Arformoterol 25 Mcg 2x/Day	Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)	Visit 5 (week 26) n=105,97,101	0.137 Liters	95% Confidence Interval 0.229

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.

Time frame: weeks 0,3,13,26

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 5 (wk 26): 2 hours Post-Dose n=58,58,53	0.234 Liter	95% Confidence Interval 0.451
Formoterol 12 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 4 (wk 13): 2 hours Post-Dose n=60,63,58	0.290 Liter	95% Confidence Interval 0.445
Formoterol 12 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 3 (wk 3): Pre-Dose n=74,77,69	0.058 Liter	95% Confidence Interval 0.38
Formoterol 12 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 5 (wk 26): Pre-Dose n=58,58,53	0.039 Liter	95% Confidence Interval 0.354
Formoterol 12 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 2 (wk 0): 2 hours Post-dose n=79,85,80	0.240 Liter	95% Confidence Interval 0.363
Formoterol 12 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 4 (wk 13): Pre-Dose n=62,63,58	0.114 Liter	95% Confidence Interval 0.368
Formoterol 12 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 3 (wk 3): 2 hours Post-dose n=75,75,69	0.206 Liter	95% Confidence Interval 0.41
Arformoterol 15 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 4 (wk 13): 2 hours Post-Dose n=60,63,58	0.233 Liter	95% Confidence Interval 0.364
Arformoterol 15 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 4 (wk 13): Pre-Dose n=62,63,58	0.005 Liter	95% Confidence Interval 0.441
Arformoterol 15 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 5 (wk 26): Pre-Dose n=58,58,53	0.057 Liter	95% Confidence Interval 0.326
Arformoterol 15 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 5 (wk 26): 2 hours Post-Dose n=58,58,53	0.202 Liter	95% Confidence Interval 0.402
Arformoterol 15 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 2 (wk 0): 2 hours Post-dose n=79,85,80	0.297 Liter	95% Confidence Interval 0.3
Arformoterol 15 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 3 (wk 3): Pre-Dose n=74,77,69	0.032 Liter	95% Confidence Interval 0.409
Arformoterol 15 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 3 (wk 3): 2 hours Post-dose n=75,75,69	0.241 Liter	95% Confidence Interval 0.401
Arformoterol 25 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 4 (wk 13): 2 hours Post-Dose n=60,63,58	0.284 Liter	95% Confidence Interval 0.423
Arformoterol 25 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 3 (wk 3): Pre-Dose n=74,77,69	0.124 Liter	95% Confidence Interval 0.37
Arformoterol 25 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 5 (wk 26): Pre-Dose n=58,58,53	0.154 Liter	95% Confidence Interval 0.371
Arformoterol 25 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 4 (wk 13): Pre-Dose n=62,63,58	0.124 Liter	95% Confidence Interval 0.447
Arformoterol 25 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 3 (wk 3): 2 hours Post-dose n=75,75,69	0.331 Liter	95% Confidence Interval 0.448
Arformoterol 25 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 2 (wk 0): 2 hours Post-dose n=79,85,80	0.330 Liter	95% Confidence Interval 0.354
Arformoterol 25 Mcg 2x/Day	Inspiratory Capacity Changes From Baseline	Visit 5 (wk 26): 2 hours Post-Dose n=58,58,53	0.368 Liter	95% Confidence Interval 0.443

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.

Time frame: weeks 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Investigator Global Evaluations Change From Baseline	Visit 4 (week 13) n=111,112,110	-0.66 units on a scale	95% Confidence Interval 1.27
Formoterol 12 Mcg 2x/Day	Investigator Global Evaluations Change From Baseline	Visit 5 (week 26) n=106,100,100	-0.74 units on a scale	95% Confidence Interval 1.2
Arformoterol 15 Mcg 2x/Day	Investigator Global Evaluations Change From Baseline	Visit 4 (week 13) n=111,112,110	-0.88 units on a scale	95% Confidence Interval 1.27
Arformoterol 15 Mcg 2x/Day	Investigator Global Evaluations Change From Baseline	Visit 5 (week 26) n=106,100,100	-0.74 units on a scale	95% Confidence Interval 1.28
Arformoterol 25 Mcg 2x/Day	Investigator Global Evaluations Change From Baseline	Visit 4 (week 13) n=111,112,110	-0.75 units on a scale	95% Confidence Interval 1.43
Arformoterol 25 Mcg 2x/Day	Investigator Global Evaluations Change From Baseline	Visit 5 (week 26) n=106,100,100	-0.76 units on a scale	95% Confidence Interval 1.65

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.

Time frame: Screening (day-14 to 0) and Treatment (week 0 - 26)

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening Period (day -14 to day 0 pre-dose)	4.10 Days Used / Week	95% Confidence Interval 2.92
Formoterol 12 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Visits 2-5 (week 0 - 26)	2.66 Days Used / Week	95% Confidence Interval 2.63
Arformoterol 15 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening Period (day -14 to day 0 pre-dose)	3.73 Days Used / Week	95% Confidence Interval 2.95
Arformoterol 15 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Visits 2-5 (week 0 - 26)	2.36 Days Used / Week	95% Confidence Interval 2.6
Arformoterol 25 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening Period (day -14 to day 0 pre-dose)	3.84 Days Used / Week	95% Confidence Interval 2.92
Arformoterol 25 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Visits 2-5 (week 0 - 26)	2.52 Days Used / Week	95% Confidence Interval 2.66

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.

Time frame: Screening (day-14 to 0) and Treatment (week 0 - 26)

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening period (day -14 to day 0 pre-dose)	2.70 Actuations / Day	95% Confidence Interval 2.72
Formoterol 12 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Visits 2-5 (week 0 - 26)	1.61 Actuations / Day	95% Confidence Interval 2.28
Arformoterol 15 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening period (day -14 to day 0 pre-dose)	2.43 Actuations / Day	95% Confidence Interval 2.69
Arformoterol 15 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Visits 2-5 (week 0 - 26)	1.59 Actuations / Day	95% Confidence Interval 2.37
Arformoterol 25 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening period (day -14 to day 0 pre-dose)	2.67 Actuations / Day	95% Confidence Interval 3.06
Arformoterol 25 Mcg 2x/Day	Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Visits 2-5 (week 0 - 26)	1.58 Actuations / Day	95% Confidence Interval 2.12

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.

Time frame: weeks 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Mean Change From Baseline in St. George's Respiratory Questionnaire	Visit 5 (week 26) n=97,94,97	-6.76 units on a scale	95% Confidence Interval 10.06
Formoterol 12 Mcg 2x/Day	Mean Change From Baseline in St. George's Respiratory Questionnaire	Visit 4 (week 13) n=105,102,105	-4.16 units on a scale	95% Confidence Interval 10.09
Arformoterol 15 Mcg 2x/Day	Mean Change From Baseline in St. George's Respiratory Questionnaire	Visit 5 (week 26) n=97,94,97	-3.73 units on a scale	95% Confidence Interval 13.14
Arformoterol 15 Mcg 2x/Day	Mean Change From Baseline in St. George's Respiratory Questionnaire	Visit 4 (week 13) n=105,102,105	-3.44 units on a scale	95% Confidence Interval 12.1
Arformoterol 25 Mcg 2x/Day	Mean Change From Baseline in St. George's Respiratory Questionnaire	Visit 4 (week 13) n=105,102,105	-1.92 units on a scale	95% Confidence Interval 9.86
Arformoterol 25 Mcg 2x/Day	Mean Change From Baseline in St. George's Respiratory Questionnaire	Visit 5 (week 26) n=97,94,97	-3.68 units on a scale	95% Confidence Interval 11.78

Secondary

Mean Values for Forced Expiratory Volume in One Second (FEV1)

Forced Expiratory Volume in one second

Time frame: Baseline (Visit 2), weeks 3, 13, 26

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0, baseline) pre dose; n=147,149,147	1.210 Liters	Standard Deviation 0.42
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) 24 hr; n=111,108,110	1.316 Liters	Standard Deviation 0.461
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visti 5 (wk 26) 6 hr; n=101,95,101	1.310 Liters	Standard Deviation 0.475
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0) 24 hr; n=141,143,141	1.378 Liters	Standard Deviation 0.497
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) pre dose; n=129,129,132	1.311 Liters	Standard Deviation 0.458
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) 24 hr; n=130,130,127	1.310 Liters	Standard Deviation 0.456
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) pre dose; n=113,111,111	1.281 Liters	Standard Deviation 0.47
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 5 (wk 26) pre dose; n=107,102,101	1.283 Liters	Standard Deviation 0.466
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 5 (wk 26) 24 hr; n=105,97,101	1.296 Liters	Standard Deviation 0.455
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0) 6 hr; n=142,145,138	1.383 Liters	Standard Deviation 0.511
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) 6 hr; n=130,125,127	1.338 Liters	Standard Deviation 0.464
Formoterol 12 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) 6 hr; n=109,109,104	1.339 Liters	Standard Deviation 0.487
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0) 6 hr; n=142,145,138	1.410 Liters	Standard Deviation 0.533
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0, baseline) pre dose; n=147,149,147	1.222 Liters	Standard Deviation 0.465
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) 24 hr; n=130,130,127	1.346 Liters	Standard Deviation 0.49
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) pre dose; n=113,111,111	1.310 Liters	Standard Deviation 0.483
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) pre dose; n=129,129,132	1.323 Liters	Standard Deviation 0.484
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) 6 hr; n=130,125,127	1.386 Liters	Standard Deviation 0.504
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) 24 hr; n=111,108,110	1.331 Liters	Standard Deviation 0.46
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0) 24 hr; n=141,143,141	1.400 Liters	Standard Deviation 0.545
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) 6 hr; n=109,109,104	1.385 Liters	Standard Deviation 0.482
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 5 (wk 26) 24 hr; n=105,97,101	1.314 Liters	Standard Deviation 0.467
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visti 5 (wk 26) 6 hr; n=101,95,101	1.355 Liters	Standard Deviation 0.457
Arformoterol 15 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 5 (wk 26) pre dose; n=107,102,101	1.291 Liters	Standard Deviation 0.453
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visti 5 (wk 26) 6 hr; n=101,95,101	1.384 Liters	Standard Deviation 0.483
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0) 24 hr; n=141,143,141	1.360 Liters	Standard Deviation 0.47
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) 6 hr; n=130,125,127	1.386 Liters	Standard Deviation 0.484
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) pre dose; n=129,129,132	1.327 Liters	Standard Deviation 0.477
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 3 (wk 3) 24 hr; n=130,130,127	1.355 Liters	Standard Deviation 0.475
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0) 6 hr; n=142,145,138	1.428 Liters	Standard Deviation 0.479
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 5 (wk 26) pre dose; n=107,102,101	1.325 Liters	Standard Deviation 0.451
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 2 (wk 0, baseline) pre dose; n=147,149,147	1.204 Liters	Standard Deviation 0.422
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) pre dose; n=113,111,111	1.308 Liters	Standard Deviation 0.473
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) 24 hr; n=111,108,110	1.294 Liters	Standard Deviation 0.444
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 4 (wk 13) 6 hr; n=109,109,104	1.361 Liters	Standard Deviation 0.463
Arformoterol 25 Mcg 2x/Day	Mean Values for Forced Expiratory Volume in One Second (FEV1)	Visit 5 (wk 26) 24 hr; n=105,97,101	1.360 Liters	Standard Deviation 0.468

Secondary

Mean Values for Inspiratory Capacity

Inspiratory capacity is the maximum volume that can be inhaled.

Time frame: Baseline (Visit 2), Weeks 3, 13, 26

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 2 (wk 0, baseline) pre-dose; n=80,86,82	1.739 Liters	Standard Deviation 0.63
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 5 (wk 26) pre-dose; n=106,101,101	1.817 Liters	Standard Deviation 0.62
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 2 (wk 0, baseline) post dose; n=80,85,81	1.976 Liters	Standard Deviation 0.73
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 5 (wk 26) post dose; n=105,100,101	1.978 Liters	Standard Deviation 0.69
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 3 (wk 3) pre-dose; n=81,83,74	1.826 Liters	Standard Deviation 0.654
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 4 (wk 13) pre-dose; n=100,94,99	1.874 Liters	Standard Deviation 0.676
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	VIsit 3 (wk 3) post dose; n=82,81,74	1.973 Liters	Standard Deviation 0.685
Formoterol 12 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 4 (wk 13) post dose; n=98,94,99	2.089 Liters	Standard Deviation 0.729
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	VIsit 3 (wk 3) post dose; n=82,81,74	2.111 Liters	Standard Deviation 0.627
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 2 (wk 0, baseline) pre-dose; n=80,86,82	1.864 Liters	Standard Deviation 0.551
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 4 (wk 13) pre-dose; n=100,94,99	1.890 Liters	Standard Deviation 0.656
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 5 (wk 26) pre-dose; n=106,101,101	1.901 Liters	Standard Deviation 0.63
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 3 (wk 3) pre-dose; n=81,83,74	1.889 Liters	Standard Deviation 0.558
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 2 (wk 0, baseline) post dose; n=80,85,81	2.161 Liters	Standard Deviation 0.624
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 4 (wk 13) post dose; n=98,94,99	2.081 Liters	Standard Deviation 0.658
Arformoterol 15 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 5 (wk 26) post dose; n=105,100,101	2.084 Liters	Standard Deviation 0.613
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 4 (wk 13) post dose; n=98,94,99	2.176 Liters	Standard Deviation 0.692
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 5 (wk 26) post dose; n=105,100,101	2.273 Liters	Standard Deviation 0.692
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 2 (wk 0, baseline) pre-dose; n=80,86,82	1.764 Liters	Standard Deviation 0.577
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	VIsit 3 (wk 3) post dose; n=82,81,74	2.108 Liters	Standard Deviation 0.632
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 3 (wk 3) pre-dose; n=81,83,74	1.909 Liters	Standard Deviation 0.633
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 4 (wk 13) pre-dose; n=100,94,99	1.962 Liters	Standard Deviation 0.64
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 5 (wk 26) pre-dose; n=106,101,101	2.070 Liters	Standard Deviation 0.691
Arformoterol 25 Mcg 2x/Day	Mean Values for Inspiratory Capacity	Visit 2 (wk 0, baseline) post dose; n=80,85,81	2.109 Liters	Standard Deviation 0.61

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.

Time frame: Baseline (Visit 2), Weeks 13, 26

Population: ITT population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 4 (week 13) n=113,112,112	3.12 units on a scale	Standard Deviation 1.05
Formoterol 12 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 2 (Baseline, Week 0) n=145,148,144	3.73 units on a scale	Standard Deviation 0.88
Formoterol 12 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 5 (week 26) n=107,100,102	3.08 units on a scale	Standard Deviation 1.04
Arformoterol 15 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 4 (week 13) n=113,112,112	3.04 units on a scale	Standard Deviation 1.17
Arformoterol 15 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 5 (week 26) n=107,100,102	3.16 units on a scale	Standard Deviation 1.28
Arformoterol 15 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 2 (Baseline, Week 0) n=145,148,144	3.88 units on a scale	Standard Deviation 0.77
Arformoterol 25 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 4 (week 13) n=113,112,112	3.04 units on a scale	Standard Deviation 1.14
Arformoterol 25 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 5 (week 26) n=107,100,102	3.01 units on a scale	Standard Deviation 1.16
Arformoterol 25 Mcg 2x/Day	Mean Values for Investigator Global Evaluations	Visit 2 (Baseline, Week 0) n=145,148,144	3.84 units on a scale	Standard Deviation 1.06

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.

Time frame: Baseline (Visit 2), weeks 13, 26

Population: ITT population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 5 (week 26) n=105, 97, 99	41.72 units on a scale	Standard Deviation 16.35
Formoterol 12 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 2 (Baseline; week 0) n=136,141,144	48.86 units on a scale	Standard Deviation 14.9
Formoterol 12 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 4 (week 13) n=114, 105, 108	43.48 units on a scale	Standard Deviation 16.53
Arformoterol 15 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 5 (week 26) n=105, 97, 99	42.69 units on a scale	Standard Deviation 17.98
Arformoterol 15 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 2 (Baseline; week 0) n=136,141,144	49.36 units on a scale	Standard Deviation 17.38
Arformoterol 15 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 4 (week 13) n=114, 105, 108	43.64 units on a scale	Standard Deviation 18.94
Arformoterol 25 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 2 (Baseline; week 0) n=136,141,144	52.40 units on a scale	Standard Deviation 17.71
Arformoterol 25 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 4 (week 13) n=114, 105, 108	49.95 units on a scale	Standard Deviation 19.67
Arformoterol 25 Mcg 2x/Day	Mean Values for St. George's Respiratory Questionnaire	Visit 5 (week 26) n=105, 97, 99	48.09 units on a scale	Standard Deviation 20.68

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.

Time frame: Baseline (Visit 2), weeks 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 2 (baseline; week 0) n=145, 148, 146	3.73 units on a scale	Standard Deviation 1.08
Formoterol 12 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 4 (week 13) n=114, 113, 115	2.83 units on a scale	Standard Deviation 1.09
Formoterol 12 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 5 (week 26) n=108, 103, 103	2.86 units on a scale	Standard Deviation 1.31
Arformoterol 15 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 5 (week 26) n=108, 103, 103	2.96 units on a scale	Standard Deviation 1.32
Arformoterol 15 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 4 (week 13) n=114, 113, 115	2.88 units on a scale	Standard Deviation 1.26
Arformoterol 15 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 2 (baseline; week 0) n=145, 148, 146	3.97 units on a scale	Standard Deviation 1.08
Arformoterol 25 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 5 (week 26) n=108, 103, 103	2.94 units on a scale	Standard Deviation 1.36
Arformoterol 25 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 2 (baseline; week 0) n=145, 148, 146	3.86 units on a scale	Standard Deviation 1.05
Arformoterol 25 Mcg 2x/Day	Mean Values for Subject Global Evaluations	Visit 4 (week 13) n=114, 113, 115	2.94 units on a scale	Standard Deviation 1.32

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.

Time frame: Baseline (Visit 2), week 13, week 26

Population: ITT population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 2 (week 0) Post-Dose n=146, 149, 146	352.19 meters	Standard Deviation 163.27
Formoterol 12 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 4 (week 13) Pre-Dose n=115, 111, 111	344.95 meters	Standard Deviation 175.53
Formoterol 12 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 5 (week 26) Post-Dose n=106, 98, 103	361.72 meters	Standard Deviation 169.96
Formoterol 12 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 2 (week 0) Pre-Dose n=147, 148, 147	334.84 meters	Standard Deviation 155.43
Formoterol 12 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 4 (week 13) Post-Dose n=116, 111, 112	352.51 meters	Standard Deviation 167.9
Formoterol 12 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 5 (week 26) Pre-Dose n=105, 100, 103	355.83 meters	Standard Deviation 181.84
Arformoterol 15 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 2 (week 0) Pre-Dose n=147, 148, 147	315.94 meters	Standard Deviation 131.74
Arformoterol 15 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 2 (week 0) Post-Dose n=146, 149, 146	332.80 meters	Standard Deviation 135.79
Arformoterol 15 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 5 (week 26) Post-Dose n=106, 98, 103	344.98 meters	Standard Deviation 122.38
Arformoterol 15 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 5 (week 26) Pre-Dose n=105, 100, 103	338.21 meters	Standard Deviation 129.68
Arformoterol 15 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 4 (week 13) Pre-Dose n=115, 111, 111	332.25 meters	Standard Deviation 140.6
Arformoterol 15 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 4 (week 13) Post-Dose n=116, 111, 112	337.28 meters	Standard Deviation 165.02
Arformoterol 25 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 5 (week 26) Pre-Dose n=105, 100, 103	337.25 meters	Standard Deviation 167.83
Arformoterol 25 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 5 (week 26) Post-Dose n=106, 98, 103	348.11 meters	Standard Deviation 174.38
Arformoterol 25 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 4 (week 13) Post-Dose n=116, 111, 112	337.68 meters	Standard Deviation 155.65
Arformoterol 25 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 2 (week 0) Pre-Dose n=147, 148, 147	328.36 meters	Standard Deviation 183.44
Arformoterol 25 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 4 (week 13) Pre-Dose n=115, 111, 111	333.63 meters	Standard Deviation 150.55
Arformoterol 25 Mcg 2x/Day	Mean Values for the 6-Minute Walk Test: Distance Walked in Meters	Visit 2 (week 0) Post-Dose n=146, 149, 146	339.81 meters	Standard Deviation 194.09

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.

Time frame: Baseline (visit 2), weeks 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 5 (week 26) n=107,103,103	2.16 units on a scale	Standard Deviation 1.1
Formoterol 12 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Baseline (visit 2, week 0) n=147,149,145	2.73 units on a scale	Standard Deviation 0.78
Formoterol 12 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 4 (week 13) n=117,113,115	2.35 units on a scale	Standard Deviation 1.03
Formoterol 12 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 3 (week 3) n=132,131,128	2.33 units on a scale	Standard Deviation 1.02
Arformoterol 15 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Baseline (visit 2, week 0) n=147,149,145	2.76 units on a scale	Standard Deviation 0.79
Arformoterol 15 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 3 (week 3) n=132,131,128	2.47 units on a scale	Standard Deviation 0.96
Arformoterol 15 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 5 (week 26) n=107,103,103	2.09 units on a scale	Standard Deviation 1.14
Arformoterol 15 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 4 (week 13) n=117,113,115	2.10 units on a scale	Standard Deviation 1.05
Arformoterol 25 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 3 (week 3) n=132,131,128	2.50 units on a scale	Standard Deviation 1.12
Arformoterol 25 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 5 (week 26) n=107,103,103	2.26 units on a scale	Standard Deviation 1.26
Arformoterol 25 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Visit 4 (week 13) n=117,113,115	2.43 units on a scale	Standard Deviation 1.21
Arformoterol 25 Mcg 2x/Day	Modified Medical Research Council Dyspnea Questionaire	Baseline (visit 2, week 0) n=147,149,145	2.91 units on a scale	Standard Deviation 0.81

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.

Time frame: Visit 4 (week 13) , Visit 5 (week 26)

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire	Visit 4 (week 13) n=105,102,105	49 Participants
Formoterol 12 Mcg 2x/Day	Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire	Visit 5 (week 26) n=97,94,97	55 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire	Visit 4 (week 13) n=105,102,105	47 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire	Visit 5 (week 26) n=97,94,97	43 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire	Visit 4 (week 13) n=105,102,105	39 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire	Visit 5 (week 26) n=97,94,97	42 Participants

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.

Time frame: weeks 13, 26

Population: ITT Population. Visit 4 n=115,113,114 Visit 5 n=108,102,103

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Number of Participants With an Improved Transitional Dyspnea Index	>= 1Unit Improvement, visit 4 (wk13) n=115,113,114	59 Participants
Formoterol 12 Mcg 2x/Day	Number of Participants With an Improved Transitional Dyspnea Index	>= 1 Unit Improvement,visit 5(wk 26) n=108,102,103	56 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With an Improved Transitional Dyspnea Index	>= 1Unit Improvement, visit 4 (wk13) n=115,113,114	59 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With an Improved Transitional Dyspnea Index	>= 1 Unit Improvement,visit 5(wk 26) n=108,102,103	49 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With an Improved Transitional Dyspnea Index	>= 1Unit Improvement, visit 4 (wk13) n=115,113,114	61 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With an Improved Transitional Dyspnea Index	>= 1 Unit Improvement,visit 5(wk 26) n=108,102,103	54 Participants

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.

Time frame: visit 6 (week 27)

Population: ITT Population

Arm	Measure	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts	1 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts	1 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts	5 Participants

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.

Time frame: Visit 6 (week 27)

Population: ITT Population

Arm	Measure	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Number of Participants With New 24-Hour Holter Monitoring Alerts	15 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With New 24-Hour Holter Monitoring Alerts	19 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With New 24-Hour Holter Monitoring Alerts	9 Participants

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.

Time frame: visit 6 (week 27)

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Glucose Evaluations	<=40 mg/dL	1 Participants
Formoterol 12 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Glucose Evaluations	>=175 mg/dL	20 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Glucose Evaluations	<=40 mg/dL	0 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Glucose Evaluations	>=175 mg/dL	55 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Glucose Evaluations	<=40 mg/dL	1 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Glucose Evaluations	>=175 mg/dL	54 Participants

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)

Time frame: visit 6 (week 27)

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Heart Rate	< 50 bpm & >= 15 bpm	6 Participants
Formoterol 12 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Heart Rate	< 120 bpm & >= 25 bpm	2 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Heart Rate	< 50 bpm & >= 15 bpm	5 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Heart Rate	< 120 bpm & >= 25 bpm	1 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Heart Rate	< 50 bpm & >= 15 bpm	2 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Heart Rate	< 120 bpm & >= 25 bpm	1 Participants

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.

Time frame: visit 6 (week 27)

Population: ITT Population

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Potassium Evaluations	<= 3mEq/L	2 Participants
Formoterol 12 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Potassium Evaluations	>= 6mEq/L	4 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Potassium Evaluations	>= 6mEq/L	1 Participants
Arformoterol 15 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Potassium Evaluations	<= 3mEq/L	4 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Potassium Evaluations	>= 6mEq/L	1 Participants
Arformoterol 25 Mcg 2x/Day	Number of Participants With Potentially Clinically Significant Potassium Evaluations	<= 3mEq/L	3 Participants

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.

Time frame: visit 4 (week 13), visit 5 (week 26)

Population: ITT population

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire	Visit 4 (week 13), n=105,102,105	46.7 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire	Visit 5 (week 26), n=97,94,97	56.7 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire	Visit 4 (week 13), n=105,102,105	46.1 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire	Visit 5 (week 26), n=97,94,97	45.7 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire	Visit 4 (week 13), n=105,102,105	37.1 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire	Visit 5 (week 26), n=97,94,97	43.3 percent of participants

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.

Time frame: visits 4 (week 13), visit 5 (week 26)

Population: 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

Arm	Measure	Group	Value (NUMBER)
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With an Improved Transitional Dyspnea Index	>=1 Unit Improvement,visit 4 (wk 13) n=115,113,114	51.3 percent of participants
Formoterol 12 Mcg 2x/Day	Percent (%) of Participants With an Improved Transitional Dyspnea Index	>=1 Unit Improvement,visit 5 (wk 26) n=108,102,103	51.9 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With an Improved Transitional Dyspnea Index	>=1 Unit Improvement,visit 4 (wk 13) n=115,113,114	52.2 percent of participants
Arformoterol 15 Mcg 2x/Day	Percent (%) of Participants With an Improved Transitional Dyspnea Index	>=1 Unit Improvement,visit 5 (wk 26) n=108,102,103	48.0 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With an Improved Transitional Dyspnea Index	>=1 Unit Improvement,visit 4 (wk 13) n=115,113,114	53.5 percent of participants
Arformoterol 25 Mcg 2x/Day	Percent (%) of Participants With an Improved Transitional Dyspnea Index	>=1 Unit Improvement,visit 5 (wk 26) n=108,102,103	52.4 percent of participants

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.

Time frame: Screening (day-14 to 0) and Treatment (week 0 - 26)

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Visits 2-5 (week 0 - 26)	2.85 Days Used / Week	95% Confidence Interval 2.64
Formoterol 12 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening Period (day -14 to day 0 pre-dose)	4.18 Days Used / Week	95% Confidence Interval 2.85
Arformoterol 15 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Visits 2-5 (week 0 - 26)	2.44 Days Used / Week	95% Confidence Interval 2.49
Arformoterol 15 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening Period (day -14 to day 0 pre-dose)	4.20 Days Used / Week	95% Confidence Interval 2.86
Arformoterol 25 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Visits 2-5 (week 0 - 26)	2.75 Days Used / Week	95% Confidence Interval 2.64
Arformoterol 25 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week	Screening Period (day -14 to day 0 pre-dose)	4.23 Days Used / Week	95% Confidence Interval 2.77

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.

Time frame: Screening (day-14 to 0) and Treatment (week 0 - 26)

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening Period (day -14 to day 0 pre-dose)	2.91 Actuations/Day	95% Confidence Interval 2.8
Formoterol 12 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Visits 2-5 (week 0 - 26)	1.71 Actuations/Day	95% Confidence Interval 2.27
Arformoterol 15 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening Period (day -14 to day 0 pre-dose)	2.68 Actuations/Day	95% Confidence Interval 2.57
Arformoterol 15 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Visits 2-5 (week 0 - 26)	1.56 Actuations/Day	95% Confidence Interval 2.32
Arformoterol 25 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Screening Period (day -14 to day 0 pre-dose)	2.97 Actuations/Day	95% Confidence Interval 3.05
Arformoterol 25 Mcg 2x/Day	Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day	Visits 2-5 (week 0 - 26)	1.65 Actuations/Day	95% Confidence Interval 2.11

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.

Time frame: weeks 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Subject Global Evaluations Change From Baseline	Visit 4 (week 13) n=112,112,114	-0.96 units on a scale	95% Confidence Interval 1.39
Formoterol 12 Mcg 2x/Day	Subject Global Evaluations Change From Baseline	Visit 5 (week 26) n=106,102,102	-0.97 units on a scale	95% Confidence Interval 1.5
Arformoterol 15 Mcg 2x/Day	Subject Global Evaluations Change From Baseline	Visit 4 (week 13) n=112,112,114	-1.11 units on a scale	95% Confidence Interval 1.51
Arformoterol 15 Mcg 2x/Day	Subject Global Evaluations Change From Baseline	Visit 5 (week 26) n=106,102,102	-1.06 units on a scale	95% Confidence Interval 1.41
Arformoterol 25 Mcg 2x/Day	Subject Global Evaluations Change From Baseline	Visit 4 (week 13) n=112,112,114	-0.89 units on a scale	95% Confidence Interval 1.49
Arformoterol 25 Mcg 2x/Day	Subject Global Evaluations Change From Baseline	Visit 5 (week 26) n=106,102,102	-0.83 units on a scale	95% Confidence Interval 1.7

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.

Time frame: weeks 0,3,13,26

Population: ITT Population. Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 3 (week 3) n=129,129,131	0.175 Liter	95% Confidence Interval 0.204
Formoterol 12 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 4 (week 13) n=113,110,110	0.155 Liter	95% Confidence Interval 0.21
Formoterol 12 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 2 (week 0) n=147,149,147	0.191 Liter	95% Confidence Interval 0.172
Formoterol 12 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 5 (week 26) n=107,100,101	0.161 Liter	95% Confidence Interval 0.209
Arformoterol 15 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 5 (week 26) n=107,100,101	0.197 Liter	95% Confidence Interval 0.229
Arformoterol 15 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 3 (week 3) n=129,129,131	0.208 Liter	95% Confidence Interval 0.2
Arformoterol 15 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 2 (week 0) n=147,149,147	0.216 Liter	95% Confidence Interval 0.157
Arformoterol 15 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 4 (week 13) n=113,110,110	0.214 Liter	95% Confidence Interval 0.225
Arformoterol 25 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 5 (week 26) n=107,100,101	0.241 Liter	95% Confidence Interval 0.209
Arformoterol 25 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 4 (week 13) n=113,110,110	0.218 Liter	95% Confidence Interval 0.214
Arformoterol 25 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 2 (week 0) n=147,149,147	0.253 Liter	95% Confidence Interval 0.179
Arformoterol 25 Mcg 2x/Day	Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline	Visit 3 (week 3) n=129,129,131	0.224 Liter	95% Confidence Interval 0.206

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.

Time frame: weeks 13, 26

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Formoterol 12 Mcg 2x/Day	Transitional (Relative Change in) Dyspnea Index	Visit 4 (week 13) n=115,113,114	1.50 units on a scale	95% Confidence Interval 2.4
Formoterol 12 Mcg 2x/Day	Transitional (Relative Change in) Dyspnea Index	Visit 5 (week 26) n=108,102,103	1.44 units on a scale	95% Confidence Interval 2.77
Arformoterol 15 Mcg 2x/Day	Transitional (Relative Change in) Dyspnea Index	Visit 4 (week 13) n=115,113,114	1.47 units on a scale	95% Confidence Interval 2.56
Arformoterol 15 Mcg 2x/Day	Transitional (Relative Change in) Dyspnea Index	Visit 5 (week 26) n=108,102,103	1.43 units on a scale	95% Confidence Interval 2.83
Arformoterol 25 Mcg 2x/Day	Transitional (Relative Change in) Dyspnea Index	Visit 4 (week 13) n=115,113,114	1.56 units on a scale	95% Confidence Interval 2.74
Arformoterol 25 Mcg 2x/Day	Transitional (Relative Change in) Dyspnea Index	Visit 5 (week 26) n=108,102,103	1.49 units on a scale	95% Confidence Interval 2.76

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

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Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations

6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)

6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes

BODE Index

Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)

Inspiratory Capacity Changes From Baseline

Investigator Global Evaluations Change From Baseline

Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week

Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day

Mean Change From Baseline in St. George's Respiratory Questionnaire

Mean Values for Forced Expiratory Volume in One Second (FEV1)

Mean Values for Inspiratory Capacity

Mean Values for Investigator Global Evaluations

Mean Values for St. George's Respiratory Questionnaire

Mean Values for Subject Global Evaluations

Mean Values for the 6-Minute Walk Test: Distance Walked in Meters

Modified Medical Research Council Dyspnea Questionaire

Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire

Number of Participants With an Improved Transitional Dyspnea Index

Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts

Number of Participants With New 24-Hour Holter Monitoring Alerts

Number of Participants With Potentially Clinically Significant Glucose Evaluations

Number of Participants With Potentially Clinically Significant Heart Rate

Number of Participants With Potentially Clinically Significant Potassium Evaluations

Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire

Percent (%) of Participants With an Improved Transitional Dyspnea Index

Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week

Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day

Subject Global Evaluations Change From Baseline

Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline

Transitional (Relative Change in) Dyspnea Index