Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

April 3, 2017 updated by: AstraZeneca

A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
590

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Forest Investigative Site 1162
      • Birmingham, Alabama, United States, 35209
        • Forest Investigative Site 1493
      • Birmingham, Alabama, United States, 35235
        • Forest Investigative Site 1620
      • Mobile, Alabama, United States, 36608
        • Forest Investigative Site 1127
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Forest Investigative Site 1613
      • Peoria, Arizona, United States, 85381
        • Forest Investigative Site 1623
      • Phoenix, Arizona, United States, 85018
        • Forest Investigative Site 1379
      • Phoenix, Arizona, United States, 85012
        • Forest Investigative Site 1582
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 1581
      • Phoenix, Arizona, United States, 85050
        • Forest Investigative Site 1571
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Forest Investigative Site 1596
    • California
      • Encinitas, California, United States, 92024
        • Forest Investigative Site 1547
      • Lakewood, California, United States, 90712
        • Forest Investigative Site 1088
      • Los Angeles, California, United States, 90025
        • Forest Investigative Site 1624
      • Los Angeles, California, United States, 90048
        • Forest Investigative Site 1927
      • Paramount, California, United States, 90723
        • Forest Investigative Site 1388
      • San Diego, California, United States, 92128
        • Forest Investigative Site 1503
      • Torrance, California, United States, 90505
        • Forest Investigative Site 1374
      • Vista, California, United States, 92083
        • Forest Investigative Site 1331
      • Walnut Creek, California, United States, 94598
        • Forest Investigative Site 2039
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Forest Investigative Site 1597
      • Colorado Springs, Colorado, United States, 80907
        • Forest Investigative Site 1137
      • Denver, Colorado, United States, 80206
        • Forest Investigative Site 0892
      • Fort Collins, Colorado, United States, 80528
        • Forest Investigative Site 2037
      • Wheat Ridge, Colorado, United States, 80033
        • Forest Investigative Site 1327
      • Wheat Ridge, Colorado, United States, 80033
        • Forest Investigative Site 2045
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Forest Investigative Site 1589
      • Stamford, Connecticut, United States, 06902
        • Forest Investigative Site 1598
    • Florida
      • Brandon, Florida, United States, 33511
        • Forest Investigative Site 1154
      • Brandon, Florida, United States, 33511
        • Forest Investigative Site 1944
      • Clearwater, Florida, United States, 33765
        • Forest Investigative Site 1152
      • Debary, Florida, United States, 32713
        • Forest Investigative Site 1617
      • Debary, Florida, United States, 32713
        • Forest Investigative Site 1959
      • Edgewater, Florida, United States, 32132
        • Forest Investigative Site 1516
      • Hollywood, Florida, United States, 33024
        • Forest Investigative Site 1403
      • Orlando, Florida, United States, 32822
        • Forest Investigative Site 1556
      • Ormond Beach, Florida, United States, 32174
        • Forest Investigative Site 1542
      • Pensacola, Florida, United States, 32504
        • Forest Investigative Site 0974
      • Tampa, Florida, United States, 33613
        • Forest Investigative Site 2047
      • Venice, Florida, United States, 34292
        • Forest Investigative Site 1565
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site 0980
      • Atlanta, Georgia, United States, 30329
        • Forest Investigative Site 1851
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site 1567
      • Lawrenceville, Georgia, United States, 30046
        • Forest Investigative Site 1607
    • Illinois
      • O'Fallon, Illinois, United States, 62269
        • Forest Investigative Site 1409
      • River Forest, Illinois, United States, 60305
        • Forest Investigative Site 2051
      • Springfield, Illinois, United States, 62702
        • Forest Investigative Site 1604
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site 1576
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Forest Investigative Site 1549
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Forest Investigative Site 2033
      • Crescent Springs, Kentucky, United States, 41017
        • Forest Investigative Site 2085
      • Louisville, Kentucky, United States, 40215
        • Forest Investigative Site 1336
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Forest Investigative Site 2024
      • New Orleans, Louisiana, United States, 70115
        • Forest Investigative Site 1430
      • Sunset, Louisiana, United States, 70584
        • Forest Investigative Site 1360
    • Maine
      • Auburn, Maine, United States, 04210
        • Forest Investigative Site 1566
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Forest Investigative Site 1333
      • Columbia, Maryland, United States, 21044
        • Forest Investigative Site 1622
      • Towson, Maryland, United States, 21204
        • Forest Investigative Site 1590
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Forest Investigative Site 1570
      • Haverhill, Massachusetts, United States, 01830
        • Forest Investigative Site 1546
      • North Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site 1029
      • Worcestor, Massachusetts, United States, 01605
        • Forest Investigative Site 1595
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Forest Investigative Site 1605
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Forest Investigative Site 1527
      • Minneapolis, Minnesota, United States, 55407
        • Forest Investigative Site 1124
      • Plymouth, Minnesota, United States, 55441
        • Forest Investigative Site 1619
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Forest Investigative Site 1587
      • Jefferson City, Missouri, United States, 65109
        • Forest Investigative Site 1572
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site 1399
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site 1599
    • Montana
      • Bozeman, Montana, United States, 59718
        • Forest Investigative Site 1831
      • Missoula, Montana, United States, 59808
        • Forest Investigative Site 1400
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Forest Investigative Site 1609
      • Lincoln, Nebraska, United States, 68506
        • Forest Investigative Site 1616
      • Omaha, Nebraska, United States, 68134
        • Forest Investigative Site 1615
    • Nevada
      • Las Vegas, Nevada, United States, 89183
        • Forest Investigative Site 1562
    • New Hampshire
      • Rochester, New Hampshire, United States, 03867
        • Forest Investigative Site 1610
    • New Jersey
      • Brick, New Jersey, United States, 08723
        • Forest Investigative Site 1558
      • Cherry Hill, New Jersey, United States, 08003
        • Forest Investigative Site 1559
      • Ocean, New Jersey, United States, 07712
        • Forest Investigative Site 1394
      • Summit, New Jersey, United States, 07901
        • Forest Investigative Site 2084
    • New York
      • Brooklyn, New York, United States, 11229
        • Forest Investigative Site 0972
      • New York, New York, United States, 10028
        • Forest Investigative Site 1425
      • New York, New York, United States, 10016
        • Forest Investigative Site 1163
      • Newburgh, New York, United States, 12550
        • Forest Investigative Site 1554
      • Syracuse, New York, United States, 13210
        • Forest Investigative Site 1563
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Forest Investigative Site 1557
      • Shelby, North Carolina, United States, 28152
        • Forest Investigative Site 1588
      • Wilmington, North Carolina, United States, 28401
        • Forest Investigative Site 1553
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site 1550
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 1134
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site 2028
      • Cincinnati, Ohio, United States, 45224
        • Forest Investigative Site 1594
      • Marion, Ohio, United States, 43302
        • Forest Investigative Site 1541
      • Toledo, Ohio, United States, 43608
        • Forest Investigative Site 1530
      • Zanesville, Ohio, United States, 43701
        • Forest Investigative Site 1393
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Forest Investigative Site 1612
      • Corvallis, Oregon, United States, 97330
        • Forest Investigative Site 1575
      • Eugene, Oregon, United States, 97404
        • Forest Investigative Site 1081
      • Portland, Oregon, United States, 97213
        • Forest Investigative Site 1580
      • Portland, Oregon, United States, 97220
        • Forest Investigative Site 1552
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Forest Investigative Site 1574
      • Beaver, Pennsylvania, United States, 15009
        • Forest Investigative Site 1577
      • Bethlehem, Pennsylvania, United States, 18020
        • Forest Investigative Site 1126
      • Erie, Pennsylvania, United States, 16506
        • Forest Investigative Site 1423
      • Hershey, Pennsylvania, United States, 17033
        • Forest Investigative Site 1504
      • Pittsburgh, Pennsylvania, United States, 15243
        • Forest Investigative Site 1146
      • Pittsburgh, Pennsylvania, United States, 15213
        • Forest Investigative Site 1569
      • Pittsburgh, Pennsylvania, United States, 15236
        • Forest Investigative Site 1548
      • Pittsburgh, Pennsylvania, United States, 15243
        • Forest Investigative Site 1560
      • Tipton, Pennsylvania, United States, 16684
        • Forest Investigative Site 1449
      • Uniontown, Pennsylvania, United States, 15401
        • Forest Investigative Site 1564
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Forest Investigative Site 1144
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Forest Investigative Site 2072
      • Easley, South Carolina, United States, 29640
        • Forest Investigative Site 1568
      • Greenville, South Carolina, United States, 29615
        • Forest Investigative Site 1506
      • Greer, South Carolina, United States, 29651
        • Forest Investigative Site 1601
      • Spartanburg, South Carolina, United States, 29303
        • Forest Investigative Site 0900
      • Union, South Carolina, United States, 29379
        • Forest Investigative Site 1450
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Forest Investigative Site 1365
    • Texas
      • Arlington, Texas, United States, 76012
        • Forest Investigative Site 1440
      • Austin, Texas, United States, 78731
        • Forest Investigative Site 1954
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 1155
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 1328
      • El Paso, Texas, United States, 79903
        • Forest Investigative Site 1332
      • Fort Worth, Texas, United States, 76104
        • Forest Investigative Site 2012
      • Killeen, Texas, United States, 76543
        • Forest Investigative Site 1902
      • San Antonio, Texas, United States, 78215
        • Forest Investigative Site 1498
      • San Antonio, Texas, United States, 78228
        • Forest Investigative Site 1614
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 1906
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 2004
    • Utah
      • Magna, Utah, United States, 84044
        • Forest Investigative Site 1600
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Forest Investigative Site 1480
      • Alexandria, Virginia, United States, 22304
        • Forest Investigative Site 1579
    • Washington
      • Spokane, Washington, United States, 99216
        • Forest Investigative Site 1573
      • Spokane, Washington, United States, 99204
        • Forest Investigative Site 1142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
  • A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

  • Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
  • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
  • Patients with any clinically significant respiratory conditions other than COPD
  • Clinical history that suggests that the patient has asthma as opposed to COPD
  • Chronic use of oxygen therapy ≥ 15 hours/day
  • Patients with clinically significant cardiovascular conditions
  • Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
  • Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
  • Current diagnosis of cancer other than basal or squamous cell skin cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
Active Comparator: 2
Inhaled formoterol fumarate 12 μg, twice per day
Drug: Formoterol Fumarate
Inhaled formoterol fumarate 12 μg, twice per day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
Time Frame: Up to study Week 56 ± 3 days
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
Up to study Week 56 ± 3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study
Time Frame: Up to study Week 52

<0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts

>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride

Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN
Up to study Week 52
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Time Frame: Up to study Week 56 ± 3 days
Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline
Up to study Week 56 ± 3 days
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
Time Frame: Up to study Week 56 ± 3 days
Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)
Up to study Week 56 ± 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LAC-MD-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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