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Chronic Obstructive Pulmonary DiseasePhase 3NCT01437540

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

A Phase 3 study testing Aclidinium Bromide/Formoterol Fumarate and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 137 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Aclidinium Bromide/Formoterol Fumarate and Formoterol Fumarate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
590 participants
Where
137 sitesUnited States
Study dates
19 Sep 2011to 30 Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

137 sites in 1 country.

137 sites in 1 country

United States137 sites

  • Forest Investigative Site 1480

    Abingdon, Virginia, 24210

  • Forest Investigative Site 1579

    Alexandria, Virginia, 22304

  • Forest Investigative Site 1440

    Arlington, Texas, 76012

  • Forest Investigative Site 1612

    Ashland, Oregon, 97520

  • Forest Investigative Site 1851

    Atlanta, Georgia, 30329

  • Forest Investigative Site 0980

    Atlanta, Georgia, 30342

  • Forest Investigative Site 1567

    Atlanta, Georgia, 30342

  • Forest Investigative Site 1566

    Auburn, Maine, 04210

  • Forest Investigative Site 1954

    Austin, Texas, 78731

  • Forest Investigative Site 1333

    Baltimore, Maryland, 21236

  • Forest Investigative Site 1574

    Beaver, Pennsylvania, 15009

  • Forest Investigative Site 1577

    Beaver, Pennsylvania, 15009

  • Forest Investigative Site 1609

    Bellevue, Nebraska, 68123

  • Forest Investigative Site 1126

    Bethlehem, Pennsylvania, 18020

  • Forest Investigative Site 1162

    Birmingham, Alabama, 35209

  • Forest Investigative Site 1493

    Birmingham, Alabama, 35209

  • Forest Investigative Site 1620

    Birmingham, Alabama, 35235

  • Forest Investigative Site 1597

    Boulder, Colorado, 80304

  • Forest Investigative Site 2033

    Bowling Green, Kentucky, 42101

  • Forest Investigative Site 1831

    Bozeman, Montana, 59718

  • Forest Investigative Site 1154

    Brandon, Florida, 33511

  • Forest Investigative Site 1944

    Brandon, Florida, 33511

  • Forest Investigative Site 1558

    Brick, New Jersey, 08723

  • Forest Investigative Site 0972

    Brooklyn, New York, 11229

  • Forest Investigative Site 1134

    Canton, Ohio, 44718

  • Forest Investigative Site 1613

    Chandler, Arizona, 85224

  • Forest Investigative Site 2072

    Charleston, South Carolina, 29406

  • Forest Investigative Site 1559

    Cherry Hill, New Jersey, 08003

  • Forest Investigative Site 1587

    Chesterfield, Missouri, 63017

  • Forest Investigative Site 1594

    Cincinnati, Ohio, 45224

  • Forest Investigative Site 2028

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 1152

    Clearwater, Florida, 33765

  • Forest Investigative Site 1137

    Colorado Springs, Colorado, 80907

  • Forest Investigative Site 1622

    Columbia, Maryland, 21044

  • Forest Investigative Site 1575

    Corvallis, Oregon, 97330

  • Forest Investigative Site 1549

    Council Bluffs, Iowa, 51503

  • Forest Investigative Site 2085

    Crescent Springs, Kentucky, 41017

  • Forest Investigative Site 1155

    Dallas, Texas, 75231

  • Forest Investigative Site 1328

    Dallas, Texas, 75231

  • Forest Investigative Site 1617

    DeBary, Florida, 32713

  • Forest Investigative Site 1959

    DeBary, Florida, 32713

  • Forest Investigative Site 0892

    Denver, Colorado, 80206

  • Forest Investigative Site 1568

    Easley, South Carolina, 29640

  • Forest Investigative Site 1516

    Edgewater, Florida, 32132

  • Forest Investigative Site 1332

    El Paso, Texas, 79903

  • Forest Investigative Site 1547

    Encinitas, California, 92024

  • Forest Investigative Site 1423

    Erie, Pennsylvania, 16506

  • Forest Investigative Site 1081

    Eugene, Oregon, 97404

  • Forest Investigative Site 1576

    Evansville, Indiana, 47713

  • Forest Investigative Site 1570

    Fall River, Massachusetts, 02720

  • Forest Investigative Site 2037

    Fort Collins, Colorado, 80528

  • Forest Investigative Site 1596

    Fort Smith, Arkansas, 72901

  • Forest Investigative Site 2012

    Fort Worth, Texas, 76104

  • Forest Investigative Site 1527

    Fridley, Minnesota, 55432

  • Forest Investigative Site 1506

    Greenville, South Carolina, 29615

  • Forest Investigative Site 1601

    Greer, South Carolina, 29651

  • Forest Investigative Site 1546

    Haverhill, Massachusetts, 01830

  • Forest Investigative Site 1504

    Hershey, Pennsylvania, 17033

  • Forest Investigative Site 1403

    Hollywood, Florida, 33024

  • Forest Investigative Site 1572

    Jefferson City, Missouri, 65109

  • Forest Investigative Site 1144

    Johnston, Rhode Island, 02919

  • Forest Investigative Site 1902

    Killeen, Texas, 76543

  • Forest Investigative Site 2024

    Lafayette, Louisiana, 70503

  • Forest Investigative Site 1088

    Lakewood, California, 90712

  • Forest Investigative Site 1562

    Las Vegas, Nevada, 89183

  • Forest Investigative Site 1607

    Lawrenceville, Georgia, 30046

  • Forest Investigative Site 1616

    Lincoln, Nebraska, 68506

  • Forest Investigative Site 1624

    Los Angeles, California, 90025

  • Forest Investigative Site 1927

    Los Angeles, California, 90048

  • Forest Investigative Site 1336

    Louisville, Kentucky, 40215

  • Forest Investigative Site 1600

    Magna, Utah, 84044

  • Forest Investigative Site 1541

    Marion, Ohio, 43302

  • Forest Investigative Site 1124

    Minneapolis, Minnesota, 55407

  • Forest Investigative Site 1400

    Missoula, Montana, 59808

  • Forest Investigative Site 1127

    Mobile, Alabama, 36608

  • Forest Investigative Site 1430

    New Orleans, Louisiana, 70115

  • Forest Investigative Site 1163

    New York, New York, 10016

  • Forest Investigative Site 1425

    New York, New York, 10028

  • Forest Investigative Site 1554

    Newburgh, New York, 12550

  • Forest Investigative Site 1029

    North Dartmouth, Massachusetts, 02747

  • Forest Investigative Site 1589

    Norwalk, Connecticut, 06851

  • Forest Investigative Site 1409

    O'Fallon, Illinois, 62269

  • Forest Investigative Site 1394

    Ocean City, New Jersey, 07712

  • Forest Investigative Site 1615

    Omaha, Nebraska, 68134

  • Forest Investigative Site 1556

    Orlando, Florida, 32822

  • Forest Investigative Site 1542

    Ormond Beach, Florida, 32174

  • Forest Investigative Site 1388

    Paramount, California, 90723

  • Forest Investigative Site 0974

    Pensacola, Florida, 32504

  • Forest Investigative Site 1623

    Peoria, Arizona, 85381

  • Forest Investigative Site 1582

    Phoenix, Arizona, 85012

  • Forest Investigative Site 1379

    Phoenix, Arizona, 85018

  • Forest Investigative Site 1581

    Phoenix, Arizona, 85020

  • Forest Investigative Site 1571

    Phoenix, Arizona, 85050

  • Forest Investigative Site 1569

    Pittsburgh, Pennsylvania, 15213

  • Forest Investigative Site 1548

    Pittsburgh, Pennsylvania, 15236

  • Forest Investigative Site 1146

    Pittsburgh, Pennsylvania, 15243

  • Forest Investigative Site 1560

    Pittsburgh, Pennsylvania, 15243

  • Forest Investigative Site 1619

    Plymouth, Minnesota, 55441

  • Forest Investigative Site 1580

    Portland, Oregon, 97213

  • Forest Investigative Site 1552

    Portland, Oregon, 97220

  • Forest Investigative Site 1557

    Raleigh, North Carolina, 27612

  • Forest Investigative Site 1365

    Rapid City, South Dakota, 57702

  • Forest Investigative Site 2051

    River Forest, Illinois, 60305

  • Forest Investigative Site 1610

    Rochester, New Hampshire, 03867

  • Forest Investigative Site 1498

    San Antonio, Texas, 78215

  • Forest Investigative Site 1614

    San Antonio, Texas, 78228

  • Forest Investigative Site 1906

    San Antonio, Texas, 78229

  • Forest Investigative Site 2004

    San Antonio, Texas, 78229

  • Forest Investigative Site 1503

    San Diego, California, 92128

  • Forest Investigative Site 1588

    Shelby, North Carolina, 28152

  • Forest Investigative Site 0900

    Spartanburg, South Carolina, 29303

  • Forest Investigative Site 1142

    Spokane, Washington, 99204

  • Forest Investigative Site 1573

    Spokane, Washington, 99216

  • Forest Investigative Site 1604

    Springfield, Illinois, 62702

  • Forest Investigative Site 1399

    St Louis, Missouri, 63141

  • Forest Investigative Site 1599

    St Louis, Missouri, 63141

  • Forest Investigative Site 1598

    Stamford, Connecticut, 06902

  • Forest Investigative Site 2084

    Summit, New Jersey, 07901

  • Forest Investigative Site 1360

    Sunset, Louisiana, 70584

  • Forest Investigative Site 1563

    Syracuse, New York, 13210

  • Forest Investigative Site 2047

    Tampa, Florida, 33613

  • Forest Investigative Site 1449

    Tipton, Pennsylvania, 16684

  • Forest Investigative Site 1530

    Toledo, Ohio, 43608

  • Forest Investigative Site 1374

    Torrance, California, 90505

  • Forest Investigative Site 1590

    Towson, Maryland, 21204

  • Forest Investigative Site 1605

    Traverse City, Michigan, 49684

  • Forest Investigative Site 1450

    Union, South Carolina, 29379

  • Forest Investigative Site 1564

    Uniontown, Pennsylvania, 15401

  • Forest Investigative Site 1565

    Venice, Florida, 34292

  • Forest Investigative Site 1331

    Vista, California, 92083

  • Forest Investigative Site 2039

    Walnut Creek, California, 94598

  • Forest Investigative Site 1327

    Wheat Ridge, Colorado, 80033

  • Forest Investigative Site 2045

    Wheat Ridge, Colorado, 80033

  • Forest Investigative Site 1553

    Wilmington, North Carolina, 28401

  • Forest Investigative Site 1550

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 1595

    Worcestor, Massachusetts, 01605

  • Forest Investigative Site 1393

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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).

Being tested
Aclidinium Bromide/Formoterol Fumarate, Formoterol Fumarate
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aclidinium Bromide/Formoterol FumarateDrug

    Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day

  • Formoterol FumarateDrug

    Inhaled formoterol fumarate 12 μg, twice per day

Study groups in NCT01437540
Study groupRoleWhat they receive
1ExperimentalInhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
Receives: Drug: Aclidinium Bromide/Formoterol Fumarate
2Active comparatorInhaled formoterol fumarate 12 μg, twice per day
Receives: Drug: Formoterol Fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)

    TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)

    Measured: Up to study Week 56 ± 3 days

Secondary outcomes (3)

  1. 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

    <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

    Measured: Up to study Week 52

  2. Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure

    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

    Measured: Up to study Week 56 ± 3 days

  3. Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline

    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)

    Measured: Up to study Week 56 ± 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2011 (estimated)
  2. Study start19 Sep 2011
  3. Primary completion31 Mar 2013
  4. Study completion30 Apr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
590 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01437540
Sponsor's protocol ID
LAC-MD-32
Status last verified
Mar 2017
First submitted
19 Sep 2011
Last updated
11 May 2017
Data monitoring committee
Yes

Publications

  • Donohue JF, Soong W, Wu X, Shrestha P, Lei A. Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD. Respir Med. 2016 Jul;116:41-8. doi: 10.1016/j.rmed.2016.05.007. Epub 2016 May 7.

    PubMed 27296819

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium Bromide/Formoterol Fumarate and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 137 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) (time frame: Up to study Week 56 ± 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01437540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.

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