AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3NCT01572792

Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Aclidinium bromide/formoterol Fixed-Dose Combination (FDC), Aclidinium bromide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 208 sites in 4 countries.

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 Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe 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 Fixed-Dose Combination (FDC), Aclidinium bromide and Formoterol Fumarate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
921 participants
Where
208 sitesin 4 countries
Study dates
Apr 2012to Jun 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

  • Completion of the treatment phase of the lead-in study, LAC-MD-31
  • Written informed consent obtained from the patient before the initiation of any study specific procedures
  • No medical contraindication as judged by the PI
  • Compliance with LAC-MD-31 study procedures and IP dosing.

Who cannot join

  • No specific exclusion criteria

Trial locations and contacts

208 sites in 4 countries.

208 sites in 4 countries

United States179 sites

  • Forest Investigative Site 1949

    Albuquerque, New Mexico, 87106

  • Forest Investigative Site 1833

    Altoona, Pennsylvania, 16601

  • Forest Investigative Site 1822

    Anaheim, California, 92801

  • Forest Investigative Site 1892

    Ann Arbor, Michigan, 48106

  • Forest Investigative Site 1827

    Anniston, Alabama, 36207

  • Forest Investigative Site 1440

    Arlington, Texas, 76012

  • Forest Investigative Site 1920

    Athens, Alabama, 35611

  • Forest Investigative Site 1900

    Atlanta, Georgia, 30312

  • Forest Investigative Site 0987

    Austell, Georgia, 30106

  • Forest Investigative Site 1924

    Baltimore, Maryland, 21237

  • Forest Investigative Site 1814

    Bangor, Maine, 04401

  • Forest Investigative Site 1821

    Bay Pines, Florida, 33744

  • Forest Investigative Site 1609

    Bellevue, Nebraska, 68123

  • Forest Investigative Site 1120

    Bellingham, Washington, 98225

  • Forest Investigative Site 1889

    Bend, Oregon, 97701

  • Forest Investigative Site 1162

    Birmingham, Alabama, 35209

  • Forest Investigative Site 1493

    Birmingham, Alabama, 35209

  • Forest Investigative Site 1937

    Birmingham, Alabama, 35216

  • Forest Investigative Site 1879

    Boerne, Texas, 78006

  • 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 1957

    Brentwood, Tennessee, 37027

  • Forest Investigative Site 1483

    Buena Park, California, 90620

  • Forest Investigative Site 1891

    Cadiz, Ohio, 43907

  • Forest Investigative Site 1828

    Canton, Georgia, 30114

  • Forest Investigative Site 1134

    Canton, Ohio, 44718

  • Forest Investigative Site 1861

    Carrollton, Texas, 75007

  • Forest Investigative Site 2072

    Charleston, South Carolina, 29406

  • Forest Investigative Site 1905

    Charleston, South Carolina, 29407

  • Forest Investigative Site 1802

    Charleston, South Carolina, 29412

  • Forest Investigative Site 1392

    Charlotte, North Carolina, 28277

  • Forest Investigative Site 1559

    Cherry Hill, New Jersey, 08003

  • Forest Investigative Site 1885

    Cincinnati, Ohio, 45219

  • Forest Investigative Site 1806

    Cincinnati, Ohio, 45231

  • Forest Investigative Site 2028

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 1903

    Cincinnati, Ohio, 45255

  • Forest Investigative Site 1364

    Clearwater, Florida, 33756

  • Forest Investigative Site 1152

    Clearwater, Florida, 33765

  • Forest Investigative Site 1875

    Clearwater, Florida, 33765

  • Forest Investigative Site 0679

    Coeur d'Alene, Idaho, 83814

  • Forest Investigative Site 1361

    Columbus, Ohio, 43207

  • Forest Investigative Site 1433

    Columbus, Ohio, 43213

  • Forest Investigative Site 1816

    Corsicana, Texas, 75110

  • Forest Investigative Site 1811

    Covington, Florida, 70433

  • Forest Investigative Site 1832

    Cumberland, Rhode Island, 02864

  • Forest Investigative Site 1890

    Dallas, Texas, 75220

  • Forest Investigative Site 0670

    DeLand, Florida, 32720

  • Forest Investigative Site 1820

    Downington, Pennsylvania, 19335

  • Forest Investigative Site 1858

    Eagle, Idaho, 83616

  • Forest Investigative Site 1089

    East Providence, Rhode Island, 02914

  • Forest Investigative Site 1516

    Edgewater, Florida, 32132

  • Forest Investigative Site 1128

    Edina, Minnesota, 55435

  • Forest Investigative Site 1332

    El Paso, Texas, 79903

  • Forest Investigative Site 2035

    Elizabeth City, North Carolina, 27909

  • Forest Investigative Site 1423

    Erie, Pennsylvania, 16508

  • Forest Investigative Site 1570

    Fall River, Massachusetts, 02720

  • Forest Investigative Site 1852

    Fall River, Massachusetts, 02720

  • Forest Investigative Site 1526

    Fayetteville, Tennessee, 37334

  • Forest Investigative Site 0990

    Fort Lauderdale, Florida, 33316

  • Forest Investigative Site 1914

    Fort Mill, South Carolina, 29707

  • Forest Investigative Site 2085

    Fort Mitchell, Kentucky, 41017

  • Forest Investigative Site 2012

    Fort Worth, Texas, 76104

  • Forest Investigative Site 1948

    Fremont, Nebraska, 68025

  • Forest Investigative Site 1156

    Fresno, California, 93726

  • Forest Investigative Site 1527

    Fridley, Minnesota, 55432

  • Forest Investigative Site 1913

    Gaffney, South Carolina, 29340

  • Forest Investigative Site 0909

    Glendale, Arizona, 85306

  • Forest Investigative Site 1380

    Golden, Colorado, 80401

  • Forest Investigative Site 1151

    Great Neck, New York, 11021

  • Forest Investigative Site 1824

    Gulf Shores, Alabama, 36542

  • Forest Investigative Site 1923

    Hackensack, New Jersey, 07601

  • Forest Investigative Site 1807

    Henderson, Nevada, 89052

  • Forest Investigative Site 1513

    Hialeah, Florida, 33012

  • Forest Investigative Site 1854

    Hialeah, Florida, 33012

  • Forest Investigative Site 1366

    High Point, North Carolina, 27262

  • Forest Investigative Site 1882

    Hollywood, Florida, 33024

  • Forest Investigative Site 1951

    Houston, Texas, 77070

  • Forest Investigative Site 1543

    Jacksonville, Florida, 32216

  • Forest Investigative Site 2088

    Jasper, Alabama, 35501

  • Forest Investigative Site 1602

    Kansas City, Missouri, 64128

  • Forest Investigative Site 1416

    Kissimmee, Florida, 34741

  • Forest Investigative Site 1899

    Langhorne, Pennsylvania, 19047

  • Forest Investigative Site 1489

    Larchmont, New York, 10538

  • Forest Investigative Site 1834

    Las Vegas, Nevada, 89128

  • Forest Investigative Site 1562

    Las Vegas, Nevada, 89183

  • Forest Investigative Site 0539

    Lexington, Kentucky, 40504

  • Forest Investigative Site 1871

    Lincoln, California, 95648

  • Forest Investigative Site 1815

    Lincoln, Nebraska, 68510

  • Forest Investigative Site 1873

    Los Angeles, California, 90073

  • Forest Investigative Site 1478

    Louisville, Kentucky, 40217

  • Forest Investigative Site 1830

    Marietta, Georgia, 30066

  • Forest Investigative Site 1091

    McKinney, Texas, 75069

  • Forest Investigative Site 2043

    Medford, Oregon, 97504

  • Forest Investigative Site 1167

    Melbourne, Florida, 32935

  • Forest Investigative Site 1432

    Miami, Florida, 33143

  • Forest Investigative Site 2041

    Minneapolis, Minnesota, 55402

  • Forest Investigative Site 1124

    Minneapolis, Minnesota, 55407

  • Forest Investigative Site 1400

    Missoula, Montana, 59808

  • Forest Investigative Site 1555

    Morgantown, West Virginia, 26505

  • Forest Investigative Site 1587

    N. Chesterfield, Missouri, 63017

  • Forest Investigative Site 1819

    Naples, Florida, 34119

  • Forest Investigative Site 1430

    New Orleans, Louisiana, 70115

  • Forest Investigative Site 550

    New York, New York, 10003

  • Forest Investigative Site 1425

    New York, New York, 10028

  • Forest Investigative Site 1945

    Newport News, Virginia, 23606

  • Forest Investigative Site 1431

    No. Dartmouth, Massachusetts, 02747

  • Forest Investigative Site 1404

    Norfolk, Virginia, 23502

  • Forest Investigative Site 1095

    Normal, Illinois, 61761

  • Forest Investigative Site 1912

    Normal, Illinois, 61761

  • Forest Investigative Site 1808

    North Miami, Florida, 33179

  • Forest Investigative Site 1915

    Oklahoma City, Oklahoma, 73103

  • Forest Investigative Site 1950

    Oldsmar, Florida, 34677

  • Forest Investigative Site 1884

    Olive Branch, Mississippi, 38654

  • Forest Investigative Site 1363

    Omaha, Nebraska, 68114

  • Forest Investigative Site 1907

    Omaha, Nebraska, 68130

  • Forest Investigative Site 1911

    Omaha, Nebraska, 68131

  • Forest Investigative Site 1908

    Omaha, Nebraska, 68134

  • Forest Investigative Site 1804

    Omaha, Nebraska, 68144

  • Forest Investigative Site 1812

    Opelousas, Louisiana, 70570

  • Forest Investigative Site 1145

    Ormond Beach, Florida, 32174

  • Forest Investigative Site 1519

    Owensboro, Kentucky, 42303

  • Forest Investigative Site 1094

    Panama City, Florida, 32405

  • Forest Investigative Site 1803

    Pembroke Pines, Florida, 32028

  • Forest Investigative Site 0974

    Pensacola, Florida, 32504

  • Forest Investigative Site 1443

    Philadelphia, Pennsylvania, 19107

  • Forest Investigative Site 1379

    Phoenix, Arizona, 85018

  • Forest Investigative Site 1863

    Phoenixville, Pennsylvania, 19460

  • Forest Investigative Site 1146

    Pittsburgh, Pennsylvania, 15243

  • Forest Investigative Site 1826

    Plano, Texas, 75001

  • Forest Investigative Site 1619

    Plymouth, Minnesota, 55441

  • Forest Investigative Site 1137

    Pueblo, Colorado, 81001

  • Forest Investigative Site 1153

    Raleigh, North Carolina, 27607

  • Forest Investigative Site 2051

    River Forest, Illinois, 60305

  • Forest Investigative Site 2064

    Riverside, California, 92506

  • Forest Investigative Site 1118

    Rochester, Minnesota, 55905

  • Forest Investigative Site 2098

    Rochester, New York, 14618

  • Forest Investigative Site 1427

    Sacramento, California, 95817

  • Forest Investigative Site 1866

    Sacramento, California, 95842

  • Forest Investigative Site 2079

    Saint Charles, Missouri, 63301

  • Forest Investigative Site 1823

    Salisbury, North Carolina, 28144

  • Forest Investigative Site 1936

    Salt Lake City, Utah, 84102

  • Forest Investigative Site 1895

    San Antonio, Texas, 78212

  • Forest Investigative Site 1125

    San Diego, California, 92103

  • Forest Investigative Site 2009

    San Diego, California, 92120

  • Forest Investigative Site 1817

    Sarasota, Florida, 34233

  • Forest Investigative Site 1918

    Scottsboro, Alabama, 35768

  • Forest Investigative Site 1330

    South Burlington, Vermont, 05403

  • Forest Investigative Site 1121

    Spartanburg, South Carolina, 29303

  • Forest Investigative Site 1977

    Spokane, Washington, 99202

  • Forest Investigative Site 1878

    Spokane, Washington, 99204

  • Forest Investigative Site 1573

    Spokane, Washington, 99216

  • Forest Investigative Site 1856

    Springfield, Missouri, 65807

  • Forest Investigative Site 1867

    Springfield, Missouri, 65807

  • Forest Investigative Site 1399

    St Louis, Missouri, 63141

  • Forest Investigative Site 1599

    St Louis, Missouri, 63141

  • Forest Investigative Site 1874

    St. Petersburg, Florida, 33704

  • Forest Investigative Site 1342

    Stevensville, Michigan, 49127

  • Forest Investigative Site 2090

    Sylvania, Ohio, 43560

  • Forest Investigative Site 0988

    Tacoma, Washington, 98405

  • Forest Investigative Site 1870

    Tacoma, Washington, 98405

  • Forest Investigative Site 2082

    Tamarac, Florida, 33321

  • Forest Investigative Site 2053

    Tampa, Florida, 33603

  • 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 1487

    Troy, Michigan, 48085

  • Forest Investigative Site 1813

    Tustin, California, 92780

  • Forest Investigative Site 1862

    Uniontown, Pennsylvania, 15473

  • Forest Investigative Site 1883

    Vista, California, 92083

  • Forest Investigative Site 1976

    Waterbury, Connecticut, 06708

  • Forest Investigative Site 1327

    Wheat Ridge, Colorado, 80033

  • Forest Investigative Site 1872

    Wheaton, Maryland, 20902

  • Forest Investigative Site 1185

    Winter Park, Florida, 32789

  • Forest Investigative Site 1860

    Winter Park, Florida, 32792

  • Forest Investigative Site 2089

    Woodstock, Georgia, 30189

  • Forest Investigative Site 1393

    Zanesville, Ohio, 43701

Other trials in United States

Australia11 sites

  • Forest Investigative Site 2253

    Adelaide, South Australia, 5000

  • Forest Investigative Site 1981

    Bedford Park, South Australia, 5042

  • Forest Investigative Site 2250

    Clayton, Victoria, 3168

  • Forest Investigative Site 1990

    Daw Park, South Australia, 5041

  • Forest Investigative Site 1972

    Fitzroy, Victoria, 3065

  • Forest Investigative Site 1986

    Geelong, Victoria, 3220

  • Forest Investigative Site 1991

    New Lambton, New South Wales, 2305

  • Forest Investigative Site 1985

    Parkville, Victoria, 3050

  • Forest Investigative Site 1987

    Redcliffe, Queensland, 4020

  • Forest Investigative Site 2251

    Toorak Gardens, South Australia, 5065

  • Forest Investigative Site 1973

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada10 sites

  • Forest Investigative Site 1904

    Langley, British Columbia, V3A 4H9

  • Forest Investigative Site 1952

    Montreal, Quebec, H2R 1V6

  • Forest Investigative Site 1859

    Québec, Quebec, G1V 4M6

  • Forest Investigative Site 1877

    Sarina, Ontario, N7T 4X3

  • Forest Investigative Site 1896

    Sarnia, Ontario, N7T 4X3

  • Forest Investigative Site 0943

    Saskatoon, Saskatchewan, S7N 0W8

  • Forest Investigative Site 1171

    Toronto, Ontario, M5T 3A9

  • Forest Investigative Site 2203

    Toronto, Ontario, M6H 3M2

  • Forest Investigative Site 905

    Vancouver, British Columbia, V5Z 1M9

  • Forest Investigative Site 0976

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

New Zealand8 sites

  • Forest Investigative Site 1027

    Auckland, 1051

  • Forest Investigative Site 1970

    Christchurch, 8011

  • Forest Investigative Site 1967

    Dunedin, 9012

  • Forest Investigative Site 1964

    Dunedin, 9058

  • Forest Investigative Site 1968

    Hamilton, 3240

  • Forest Investigative Site 1965

    Tauranga, 3110

  • Forest Investigative Site 1980

    Tauranga, 3112

  • Forest Investigative Site 1025

    Wellington, 7366

Other trials in New Zealand

About this study

Official title: A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.

Being tested
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC), Aclidinium bromide, Formoterol Fumarate, Placebo
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 Fixed-Dose Combination (FDC)Drug

    Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day

  • Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)Drug

    Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day

  • Aclidinium bromideDrug

    Inhaled Aclidinium bromide 400 μg, twice per day

  • Formoterol FumarateDrug

    Inhaled Formoterol Fumarate 12 μg, twice per day

  • PlaceboDrug

    Inhaled dose-matched placebo, twice per day

Study groups in NCT01572792
Study groupRoleWhat they receive
1ExperimentalAclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
Receives: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
2ExperimentalAclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
Receives: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
3Active comparatorAclidinium bromide 400 μg
Receives: Drug: Aclidinium bromide
4Active comparatorFormoterol Fumarate 12 μg
Receives: Drug: Formoterol Fumarate
5Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Patients to Experience Any Treatment-emergent Adverse Event

    For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study

    Measured: Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)

Secondary outcomes (3)

  1. Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis

    Potentially clinically significant change:

    >1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid <0.85 x lower limit of normal (LLN) or > 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH <0.95 x LLN or >1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity >1.1 × ULN

    The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study

    Measured: Baseline of lead-in study to end of treatment (up to Week 52)

  2. Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value

    Measured: Baseline of lead-in study to end of treatment (up to Week 52)

  3. Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)

    Potentially clinically significant change:

    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 Weight increase or decrease ≥7% from baseline

    The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study

    Measured: Baseline of lead-in study to end of treatment (up to Week 52)

Timeline

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

  1. First posted6 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2013
  4. Study completionJun 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
921 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01572792
Sponsor's protocol ID
LAC-MD-36
Status last verified
Feb 2017
First submitted
4 Apr 2012
Last updated
21 Apr 2017
Data monitoring committee
No

Publications

  • D'Urzo A, Rennard S, Kerwin E, Donohue JF, Lei A, Molins E, Leselbaum A. A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. Respir Med. 2017 Apr;125:39-48. doi: 10.1016/j.rmed.2017.02.008. Epub 2017 Feb 16.

    PubMed 28340861

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium bromide/formoterol Fixed-Dose Combination (FDC), Aclidinium bromide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 208 sites in 4 countries.

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 4 inclusion and 1 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 208 sites in United States, Australia, Canada, New Zealand. 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. Some participants in this study may receive a placebo. 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 21 Apr 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 Any Treatment-emergent Adverse Event (time frame: Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)). 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 NCT01572792, 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 21 Apr 2017.

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