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Chronic Obstructive Pulmonary DiseasePhase 3LAS-MD-38NCT01045161

Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

A Phase 3 study testing Aclidinium bromide in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 112 sites in 2 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 study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
544 participants
Where
112 sitesin 2 countries
Study dates
Mar 2009to Jun 2011
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

  • A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
  • Current or former cigarette smokers

Who cannot join

  • Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
  • Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
  • Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
  • History or presence of asthma verified from medical records
  • Chronic use of oxygen therapy greater than or equal to 15 hours per day
  • Patient with uncontrolled infection due to HIV and/or active hepatitis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics
  • Patients with clinically significant cardiovascular conditions, including myocardial infarction during 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.

Trial locations and contacts

112 sites in 2 countries.

112 sites in 2 countries

United States110 sites

  • Forest Investigative Site 1480

    Abingdon, Virginia, 24210

  • Forest Investigative Site 1486

    Albuquerque, New Mexico, 87108

  • Forest Investigative Site 1389

    Amarillo, Texas, 79106

  • Forest Investigative Site 1479

    Anderson, Indiana, 46011

  • Forest Investigative Site 1440

    Arlington, Texas, 76012

  • Forest Investigative Site 1386

    Atlanta, Georgia, 30328

  • Forest Investigative Site 1494

    Austin, Texas, 78756

  • Forest Investigative Site 1412

    Baltimore, Maryland, 21201

  • Forest Investigative Site 1354

    Bellevue, Nebraska, 68005

  • Forest Investigative Site 1367

    Bellevue, Nebraska, 68123

  • Forest Investigative Site 1493

    Birmingham, Alabama, 35209

  • Forest Investigative Site 1419

    Birmingham, Alabama, 35233

  • Forest Investigative Site 2033

    Bowling Green, Kentucky, 42101

  • Forest Investigative Site 1442

    Brockton, Massachusetts, 02301

  • Forest Investigative Site 1411

    Calhoun, Georgia, 30701

  • Forest Investigative Site 1392

    Charlotte, North Carolina, 28277

  • Forest Investigative Site 1405

    Chelsea, Michigan, 48118

  • Forest Investigative Site 1136

    Cincinnati, Ohio, 45227

  • Forest Investigative Site 1371

    Cincinnati, Ohio, 45245

  • Forest Investigative Site 1364

    Clearwater, Florida, 33756

  • Forest Investigative Site 0679

    Coeur d'Alene, Idaho, 83814

  • Forest Investigative Site 1377

    Collegeville, Pennsylvania, 19426

  • Forest Investigative Site 1144

    Columbia, South Carolina, 29201

  • Forest Investigative Site 1361

    Columbus, Ohio, 43209

  • Forest Investigative Site 1433

    Columbus, Ohio, 43213

  • Forest Investigative Site 1517

    Easley, South Carolina, 29640

  • Forest Investigative Site 1516

    Edgewater, Florida, 32132

  • Forest Investigative Site 1128

    Edina, Minnesota, 58435

  • Forest Investigative Site 1385

    Elk Grove Village, Illinois, 60007

  • Forest Investigative Site 1423

    Erie, Pennsylvania, 16508

  • Forest Investigative Site 2022

    Evansville, Indiana, 47714

  • Forest Investigative Site 1421

    Fall River, Massachusetts, 02720

  • Forest Investigative Site 1526

    Fayetteville, Tennessee, 37337

  • Forest Investigative Site 1428

    Feasterville, Pennsylvania, 19053

  • Forest Investigative Site 1476

    Fremont, Nebraska, 68025

  • Forest Investigative Site 1527

    Fridley, Minnesota, 55432

  • Forest Investigative Site 2065

    Fullerton, California, 92835

  • Forest Investigative Site 1380

    Golden, Colorado, 80401

  • Forest Investigative Site 1506

    Grenville, South Carolina, 29615

  • Forest Investigative Site 1090

    Hazard, Kentucky, 41701

  • Forest Investigative Site 1359

    Henderson, Nevada, 89014

  • Forest Investigative Site 1366

    High Point, North Carolina, 27262

  • Forest Investigative Site 1403

    Hollywood, Florida, 33021

  • Forest Investigative Site 1485

    Homestead, Florida, 33032

  • Forest Investigative Site 1375

    Houston, Texas, 77074

  • Forest Investigative Site 1444

    Houston, Texas, 77079

  • Forest Investigative Site 1401

    Houston, Texas, 77083

  • Forest Investigative Site 1381

    Houston, Texas, 77479

  • Forest Investigative Site 1357

    Hurst, Texas, 76054

  • Forest Investigative Site 1441

    Indianapolis, Indiana, 46256

  • Forest Investigative Site 1406

    Iowa City, Iowa, 52240

  • Forest Investigative Site 1445

    Johnston, Rhode Island, 02919

  • Forest Investigative Site 1356

    Knoxville, Tennessee, 37909

  • Forest Investigative Site 1417

    Knoxville, Tennessee, 37920

  • Forest Investigative Site 1489

    Larchmont, New York, 10538

  • Forest Investigative Site 1355

    Las Vegas, Nevada, 89123

  • Forest Investigative Site 1528

    Lawrenceville, Georgia, 30046

  • Forest Investigative Site 1477

    Lincoln, Rhode Island, 02865

  • Forest Investigative Site 0889

    Livonia, Michigan, 48152

  • Forest Investigative Site 1402

    Lynchburg, Virginia, 24501

  • Forest Investigative Site 2018

    Medford, Oregon, 97504

  • Forest Investigative Site 2043

    Medford, Oregon, 97504

  • Forest Investigative Site 1352

    Miami, Florida, 33126

  • Forest Investigative Site 1124

    Minneapolis, Minnesota, 55403

  • Forest Investigative Site 1400

    Missoula, Montana, 59808

  • Forest Investigative Site 1413

    Muscle Shoals, Alabama, 35662

  • Forest Investigative Site 1391

    Naples, Florida, 34110

  • Forest Investigative Site 1451

    National City, California, 91950

  • Forest Investigative Site 1430

    New Orleans, Louisiana, 70115

  • Forest Investigative Site 1446

    New Orleans, Louisiana, 70119

  • Forest Investigative Site 1425

    New York, New York, 10028

  • Forest Investigative Site 1404

    Norfolk, Virginia, 23502

  • Forest Investigative Site 1029

    North Dartmouth, Massachusetts, 02747

  • Forest Investigative Site 1518

    North East, Maryland, 21901

  • Forest Investigative Site 1373

    North Syracuse, New York, 13212

  • Forest Investigative Site 1409

    O'Fallon, Illinois, 62269

  • Forest Investigative Site 1362

    Oklahoma City, Oklahoma, 73112

  • Forest Investigative Site 1363

    Omaha, Nebraska, 68114

  • Forest Investigative Site 1390

    Omaha, Nebraska, 68130

  • Forest Investigative Site 1422

    Omaha, Nebraska, 68134

  • Forest Investigative Site 1388

    Paramount, California, 90723

  • Forest Investigative Site 1353

    Pell City, Alabama, 35128

  • Forest Investigative Site 1443

    Philadelphia, Pennsylvania, 19107

  • Forest Investigative Site 1379

    Phoenix, Arizona, 85018

  • Forest Investigative Site 1510

    Pittsburgh, Pennsylvania, 15221

  • Forest Investigative Site 1426

    Plano, Texas, 75093

  • Forest Investigative Site 1376

    Port Orange, Florida, 32129

  • Forest Investigative Site 1447

    Pueblo, Colorado, 81001

  • Forest Investigative Site 1358

    Richmond, Virginia, 23294

  • Forest Investigative Site 1118

    Rochester, Minnesota, 55904

  • Forest Investigative Site 1424

    Rolling Hill Estates, California, 90274

  • Forest Investigative Site 1427

    Sacramento, California, 95817

  • Forest Investigative Site 1418

    San Diego, California, 92120

  • Forest Investigative Site 2009

    San Diego, California, 92120

  • Forest Investigative Site 1149

    South Bend, Indiana, 46617

  • Forest Investigative Site 1372

    South Miami, Florida, 33143

  • Forest Investigative Site 1399

    St Louis, Missouri, 63141

  • Forest Investigative Site 1360

    Sunset, Louisiana, 70584

  • Forest Investigative Site 0988

    Tacoma, Washington, 98405

  • Forest Investigative Site 1449

    Tipton, Pennsylvania, 16684

  • Forest Investigative Site 1530

    Toledo, Ohio, 43608

  • Forest Investigative Site 1410

    Tomball, Texas, 77375

  • Forest Investigative Site 1080

    Topeka, Kansas, 66606

  • Forest Investigative Site 1374

    Torrance, California, 90505

  • Forest Investigative Site 1407

    Trinity, Florida, 34655

  • Forest Investigative Site 1487

    Troy, Michigan, 48085

  • Forest Investigative Site 1450

    Union, South Carolina, 29379

  • Forest Investigative Site 1331

    Vista, California, 92083

  • Forest Investigative Site 1185

    Winter Park, Florida, 32789

  • Forest Investigative Site 1393

    Zanesville, Ohio, 43701

Other trials in United States

Canada2 sites

  • Forest Investigative Site 1177

    Vancouver, British Columbia, V5Z 4E1

  • Forest Investigative Site 0969

    Windsor, Ontario, N8X 5A6

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose

The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.

Being tested
Aclidinium bromide, Placebo
Keywords
Chronic Obstructive Pulmonary Disease, COPD, 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 bromideDrug

    Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.

  • PlaceboDrug

    Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment

Study groups in NCT01045161
Study groupRoleWhat they receive
1ExperimentalAclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks
Receives: Drug: Aclidinium bromide
2ExperimentalAclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks
Receives: Drug: Aclidinium bromide
3Placebo comparatorDose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
Receives: Drug: Placebo

What is being measured

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

  1. Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)

    Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

    Measured: Change from baseline (Week 0) to Week 12

  2. Part B: Morning Predose (Trough) FEV1

    Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)

    Measured: Change from baseline (Week 0) to 52 Weeks

Secondary outcomes (2)

  1. Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)

    Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)

    Measured: Change from baseline (Week 0) to Week 12

  2. Part B: Peak FEV1

    Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)

    Measured: Change from baseline (Week 0) to 52 Weeks

Timeline

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

  1. First posted8 Jan 2010 (estimated)
  2. Study startMar 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

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
544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01045161
Sponsor's protocol ID
LAS-MD-38
Acronym
LAS-MD-38
Status last verified
Nov 2016
First submitted
7 Jan 2010
Last updated
23 Jan 2017
Data monitoring committee
No

Publications

  • Rennard SI, Scanlon PD, Ferguson GT, Rekeda L, Maurer BT, Garcia Gil E, Caracta CF. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013 Dec;33(12):893-904. doi: 10.1007/s40261-013-0138-1.

    PubMed 24085591

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium bromide in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 112 sites in 2 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 2 inclusion and 8 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Canada. 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 9 Dec 2015). 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?

Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) (time frame: Change from baseline (Week 0) to Week 12). 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 NCT01045161, 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 23 Jan 2017.

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