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

Sumitomo Pharma America, Inc.443 enrolled

Overview

To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).

This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD. Study participation will be over approximately 6 months. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

443

Conditions

Chronic Obstructive Pulmonary Disease Bronchitis Emphysema

Interventions

Arformoterol tartrate inhalation solutionDRUG

Arformoterol 15 ųg BID by nebulization

Arformoterol 25 ųg BIDDRUG

Arformoterol 25 ųg BID by nebulization

Formoterol 12 ųg BIDDRUG

Formoterol fumarate 12 ųg BID via aerolizer/DPI

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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)

Locations (60)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

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)

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)

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)

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

Data from ClinicalTrials.gov

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Placebo nebule or placebo aerolizer

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Jasper, Alabama, United States

Unnamed facility

Mobile, Alabama, United States

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Carmichael, California, United States

Unnamed facility

Fullerton, California, United States

Unnamed facility

Long Beach, California, United States

Unnamed facility

Paramount, California, United States

Unnamed facility

Rancho Mirage, California, United States

Unnamed facility

San Diego, California, United States

...and 50 more locations

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

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)

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)

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)

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)

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)

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

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

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

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

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

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

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

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

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

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)

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

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)

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)

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

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

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

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

Mean Values for Inspiratory Capacity

Inspiratory capacity is the maximum volume that can be inhaled.

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

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