AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3NCT01437397

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

A Phase 3 study testing Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 222 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 assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the… 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, Aclidinium Bromide and Formoterol Fumarate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,692 participants
Where
222 sitesin 4 countries
Study dates
Sep 2011to Feb 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

  • Male or female patients at least 40 years of age
  • Current or former cigarette smoker 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 GOLD guidelines and stable airway obstruction. Patients had to have a postbronchodilator FEV1/FVC ratio < 70% at Visit 1 (GOLD, 2010)
  • Post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of predicted value. FEV1 was measured at the Screening Visit (Visit 1) 10 to 15 minutes after inhalation of albuterol/salbutamol. Predicted normal used for calculation purposes were based on National Health and Nutrition Examination Survey III predicted values (Hankinson et al, 1999)
  • Able to perform acceptable and repeatable pulmonary function testing for FEV1 according to ATS/ERS criteria (Miller et al, 2005) at Screening Visit (Visit 1) and throughout their participation in the trial
  • Negative serum β-human chorionic gonadotropin pregnancy test at Visit 1 and must have been using hormonal contraceptives or a barrier method plus a spermicidal agent; otherwise at least 1-year postmenopausal or surgically sterile, defined as having a hysterectomy or tubal ligation (applied to female patients only)
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  • Judged by the Principal Investigator to be in otherwise good stable health based on medical history, physical examination, ECGs, and routine laboratory data evaluations
  • Patients previously randomized in an aclidinium monotherapy trial were permitted as long as it had been at least 6 months since the completion of their previous trial participation
  • Able to understand the study procedures and be willing to participate in the study as indicated by signing the informed consent

Who cannot join

  • Hospitalization for an acute COPD exacerbation within 3 months before Visit 1
  • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1. Patients who developed a respiratory tract infection or COPD exacerbation during the washout or run-in period were discontinued from the study before randomization
  • Any clinically significant respiratory conditions other than COPD, including active tuberculosis, history of interstitial lung disease, pulmonary thromboembolic disease, history of α1-antitrypsin deficiency, pulmonary resection, lung volume surgery, or any other thoracic surgery during the past 12 months, history of bronchiectasis secondary to respiratory diseases other than COPD (eg, cystic fibrosis, Kartagener syndrome), post organ transplantation, or expected to require thoracotomy or other lung surgery during the study
  • Clinical history suggesting that the patient had asthma as opposed to COPD (Study Physician was to be contacted to discuss eligibility, if necessary)
  • Chronic use of oxygen therapy ≥ 15 hours/day
  • Body mass index(BMI) ≥ 40 kg/m2
Show all 26Show fewer
  • Patients who intended to start a pulmonary rehabilitation program during the trial were excluded, as well as those who finished or started it within 3 months prior to Screening Visit
  • Clinically significant cardiovascular conditions including: myocardial infarction within the previous 6 months; newly diagnosed arrhythmia within the previous 3 months; unstable angina; unstable arrhythmia that had required changes in pharmacological therapy or other intervention within the previous 6 months; the presence of an automated implantable cardioverter-defibrillator; history of thoracic surgery within the past year before screening; hospitalization within the previous 12 months for heart failure of New York Heart Association functional class III (marked limitation of physical activity and only comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea), or class IV (unable to carry out any physical activity without discomfort) (Criteria Committee of the New York Heart Association criteria, 1994)
  • Any uncontrolled infection that may have placed the patient at risk resulting from human immunodeficiency virus, active hepatitis and/or patients with diagnosed active tuberculosis
  • QTcB > 470 msec in the resting ECGs performed at Screening (Visit 1), as indicated in the centralized ECG vendor generated report. Patients who were on a stable dose of medication that may prolong the QTc, but had a documented, stable, and normal QTc, could have been considered
  • QTcB > 470 msec in the resting ECGs performed before randomization at Visit 2, as indicated in the paper tracing generated by the Sponsor-provided ECG equipment
  • Clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters other than QTc, or in the physical examination or vital signs at Visit 1 except for those related to COPD
  • History of drug or alcohol abuse within the previous 5 years
  • Any other serious or uncontrolled physical or mental condition/disease that, as judged by the Investigator, could have placed the patient at higher risk derived from his/her participation in the study, could have confounded the results of the study, or would be likely to have prevented the patient from complying with the requirements of the study or completing the study. If there was a history of such disease, but the condition had been stable for more than 1 year and was judged by the Investigator not to interfere with the patient's participation in the study, the patient may have been included, with the documented approval of the Study Physician
  • History of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) or a history of acute urinary retention, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or narrow-angle glaucoma. (Note: Patients who had well controlled, stable, asymptomatic benign prostatic hyperplasia were not to be excluded)
  • Sitting, resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 100 mm Hg at Visit 1 and Visit 2
  • Unable to use a multidose dry-powder inhaler or a pressurized metered-dose inhaler
  • Treatment with any other investigational product within 30 days (or 6 half-lives, whichever was longer) before Visit 1
  • Previous participation in a clinical trial with aclidinium bromide in an FDC therapy
  • Pregnant or breastfeeding
  • Current diagnosis of cancer (present in the patient) other than basal or squamous cell skin cancer. Patients who had a history of cancer must have been cleared before Visit 1 (Screening) on a case-by-case basis
  • Patients who did not maintain regular day/night, waking/sleeping cycles (eg, night shift workers)
  • Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication (Appendix III of the protocol, which can be found in Appendix 16.1.1 of this report)
  • Patients who were unlikely to be compliant with study requirements (eg, take their medication, complete their electronic diaries, attend clinic at the required times)
  • Patients who were employees or relatives of employees of the investigative study center, FRI, Almirall, SA, or Pharmaceutical Product Development (PPD, Inc.)
  • Patients who had any other conditions that, in the Investigator's opinion, might have indicated the patient to be unsuitable for the study or supported excluding the patient from the study

Trial locations and contacts

222 sites in 4 countries.

222 sites in 4 countries

United States193 sites

  • Forest Investigative Site 1982

    Albany, Georgia, 31707

  • 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 1587

    Chesterfield, Missouri, 63017

  • 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, 45245

  • Forest Investigative Site 1855

    Clairton, Pennsylvania, 15025

  • 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, Louisiana, 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 1893

    Florence, Alabama, 35630

  • 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 1809

    Fountain Valley, California, 92708

  • 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 1865

    Hollywood, Maryland, 20636

  • 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 1902

    Killeen, Texas, 76543

  • 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 1958

    Mesa, Arizona, 85206

  • Forest Investigative Site 1868

    Miami, Florida, 33135

  • Forest Investigative Site 1432

    Miami, Florida, 33143

  • Forest Investigative Site 1979

    Miami, Florida, 33144

  • 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 1819

    Naples, Florida, 34119

  • Forest Investigative Site 1430

    New Orleans, Louisiana, 70115

  • Forest Investigative Site 0550

    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 1404

    Norfolk, Virginia, 23502

  • Forest Investigative Site 1095

    Normal, Illinois, 61761

  • Forest Investigative Site 1912

    Normal, Illinois, 61761

  • Forest Investigative Site 1029

    North Dartmouth, Massachusetts, 02747

  • Forest Investigative Site 1431

    North Dartmouth, Massachusetts, 02747

  • Forest Investigative Site 1808

    North Miami Beach, 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, 33028

  • Forest Investigative Site 974

    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 1829

    Saint Cloud, Florida, 34769

  • Forest Investigative Site 1823

    Salisbury, North Carolina, 28144

  • Forest Investigative Site 1936

    Salt Lake City, Utah, 84102

  • Forest Investigative Site 0526

    San Angelo, Texas, 76904

  • Forest Investigative Site 1895

    San Antonio, Texas, 78212

  • Forest Investigative Site 1125

    San Diego, California, 92103

  • Forest Investigative Site 1898

    San Diego, California, 92111

  • 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, 25403

  • 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, 65803

  • 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 1876

    St. Petersburg, Florida, 33701

  • 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, Western 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, 3011

  • 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, S7N0W8

  • Forest Investigative Site 1171

    Toronto, Ontario, M5T 3A9

  • Forest Investigative Site 2203

    Toronto, Ontario, M6H 3M2

  • Forest Investigative Site 0905

    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, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.

Being tested
Aclidinium Bromide/Formoterol Fumarate, 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 FumarateDrug

    Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day

  • Aclidinium Bromide/Formoterol FumarateDrug

    Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day

  • Aclidinium BromideDrug

    Inhaled Aclidinium 400 μg, twice per day

  • Formoterol FumarateDrug

    Inhaled Formoterol 12 μg, twice per day

  • PlaceboDrug

    Inhaled dose-matched placebo, twice per day

Study groups in NCT01437397
Study groupRoleWhat they receive
1ExperimentalAclidinium/formoterol Fixed Dose Combination (FDC) 400/12μg
Receives: Drug: Aclidinium Bromide/Formoterol Fumarate
2ExperimentalAclidinium/formoterol Fixed Dose Combination (FDC) 400/6μg
Receives: Drug: Aclidinium Bromide/Formoterol Fumarate
3Active comparatorAclidinium monotherapy 400 μg
Receives: Drug: Aclidinium Bromide
4Active comparatorFormoterol monotherapy 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. Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)

    Measured: Week 24 of treatment

  2. Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1)

    Measured: Week 24 of treatment

Secondary outcomes (2)

  1. Change in Transition Dyspnea Index (TDI) Focal Score

    The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort).TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate "no change". The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9.

    Measured: Week 24 of treatment

  2. Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score

    St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 2 parts with 3 dimension scores (a symptom score and an activity and impacts score). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).

    Measured: Week 24 of treatment

Timeline

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

  1. First posted20 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 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
1,692 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01437397
Sponsor's protocol ID
LAC-MD-31
Status last verified
Jan 2017
First submitted
19 Sep 2011
Last updated
23 Mar 2017
Data monitoring committee
No

Publications

  • Singh D, D'Urzo AD, Donohue JF, Kerwin EM, Molins E, Chuecos F, Ribera A, Jarreta D. An Evaluation Of Single And Dual Long-Acting Bronchodilator Therapy As Effective Interventions In Maintenance Therapy-Naive Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 6;14:2835-2848. doi: 10.2147/COPD.S217710. eCollection 2019.

    PubMed 31827323

  • Singh D, D'Urzo AD, Chuecos F, Munoz A, Garcia Gil E. Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol. Respir Res. 2017 May 30;18(1):106. doi: 10.1186/s12931-017-0583-0.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 222 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 9 inclusion and 26 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 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 23 Mar 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?

Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (time frame: Week 24 of treatment). The study lists 2 primary outcomes in all. 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 NCT01437397, which also lists 5 linked publications.

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 23 Mar 2017.

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