MedDataX Logo

Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

NCT ID: NCT01044459

Last Updated: 2017-04-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

605 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

NCT00891462

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

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

NCT01045161

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

NCT00970268

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01001494

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00500318

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aclidinium Bromide 200 µg

aclidinium bromide, inhaled, 52 weeks of treatment

Group Type EXPERIMENTAL

Aclidinium Bromide 200 µg

Intervention Type DRUG

aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment

Aclidinium Bromide 400 µg

aclidinium bromide, inhaled, 52 weeks of treatment

Group Type EXPERIMENTAL

Aclidinium Bromide 400 µg

Intervention Type DRUG

aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aclidinium Bromide 200 µg

aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment

Intervention Type DRUG

Aclidinium Bromide 400 µg

aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted
* Current or former cigarette smokers

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esther Garcia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Forest Investigative Site 1162

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 1127

Mobile, Alabama, United States

Site Status

Forest Investigative Site 1475

Scottsdale, Arizona, United States

Site Status

Forest Investigative Site 1338

Tempe, Arizona, United States

Site Status

Forest Investigative Site 1349

Tucson, Arizona, United States

Site Status

Forest Investigative Site 1483

Buena Park, California, United States

Site Status

Forest Investigative Site 1350

Foothill Ranch, California, United States

Site Status

Forest Investigative Site 1509

Fresno, California, United States

Site Status

Forest Investigative Site 2065

Fullerton, California, United States

Site Status

Forest Investigative Site 1502

Huntington Park, California, United States

Site Status

Forest Investigative Site 1088

Lakewood, California, United States

Site Status

Forest Investigative Site 1534

Long Beach, California, United States

Site Status

Forest Investigative Site 2209

Los Angeles, California, United States

Site Status

Forest Investigative Site 1122

Orange, California, United States

Site Status

Forest Investigative Site 1508

Palm Springs, California, United States

Site Status

Forest Investigative Site 2064

Riverside, California, United States

Site Status

Forest Investigative Site 1533

Sacramento, California, United States

Site Status

Forest Investigative Site 2009

San Diego, California, United States

Site Status

Forest Investigative Site 1439

San Diego, California, United States

Site Status

Forest Investigative Site 1503

San Diego, California, United States

Site Status

Forest Investigative Site 1347

San Jose, California, United States

Site Status

Forest Investigative Site 1344

Spring Valley, California, United States

Site Status

Forest Investigative Site 2039

Walnut Creek, California, United States

Site Status

Forest Investigative Site 2037

Fort Collins, Colorado, United States

Site Status

Forest Investigative Site 1327

Wheat Ridge, Colorado, United States

Site Status

Forest Investigative Site 1104

Hartford, Connecticut, United States

Site Status

Forest Investigative Site 1482

Stamford, Connecticut, United States

Site Status

Forest Investigative Site 1346

Newark, Delaware, United States

Site Status

Forest Investigative Site 1154

Brandon, Florida, United States

Site Status

Forest Investigative Site 1152

Clearwater, Florida, United States

Site Status

Forest Investigative Site 1514

Coral Gables, Florida, United States

Site Status

Forest Investigative Site 0670

DeLand, Florida, United States

Site Status

Forest Investigative Site 1516

Edgewater, Florida, United States

Site Status

Forest Investigative Site 0990

Fort Lauderdale, Florida, United States

Site Status

Forest Investigative Site 1513

Hialeah, Florida, United States

Site Status

Forest Investigative Site 1420

Miami, Florida, United States

Site Status

Forest Investigative Site 1432

Miami, Florida, United States

Site Status

Forest Investigative Site 1484

Miramar, Florida, United States

Site Status

Forest Investigative Site 1340

Ocala, Florida, United States

Site Status

Forest Investigative Site 1488

Pembroke Pines, Florida, United States

Site Status

Forest Investigative Site 0974

Pensacola, Florida, United States

Site Status

Forest Investigative Site 1397

Port Charlotte, Florida, United States

Site Status

Forest Investigative Site 1383

Port Orange, Florida, United States

Site Status

Forest Investigative Site 2082

Tamarac, Florida, United States

Site Status

Forest Investigative Site 2047

Tampa, Florida, United States

Site Status

Forest Investigative Site 1395

Valrico, Florida, United States

Site Status

Forest Investigative Site 0980

Atlanta, Georgia, United States

Site Status

Forest Investigative Site 1491

Atlanta, Georgia, United States

Site Status

Forest Investigative Site 0987

Austell, Georgia, United States

Site Status

Forest Investigative Site 1532

Columbus, Georgia, United States

Site Status

Forest Investigative Site 2051

River Forest, Illinois, United States

Site Status

Forest Investigative Site 0989

Skokie, Illinois, United States

Site Status

Forest Investigative Site 1436

Avon, Indiana, United States

Site Status

Forest Investigative Site 2085

Crescent Springs, Kentucky, United States

Site Status

Forest Investigative Site 1520

Crestview Hills, Kentucky, United States

Site Status

Forest Investigative Site 0539

Lexington, Kentucky, United States

Site Status

Forest Investigative Site 1336

Louisville, Kentucky, United States

Site Status

Forest Investigative Site 1478

Louisville, Kentucky, United States

Site Status

Forest Investigative Site 2024

Lafayette, Louisiana, United States

Site Status

Forest Investigative Site 1333

Baltimore, Maryland, United States

Site Status

Forest Investigative Site 1421

Fall River, Massachusetts, United States

Site Status

Forest Investigative Site 1342

Stevensville, Michigan, United States

Site Status

Forest Investigative Site 1438

Ypsilanti, Michigan, United States

Site Status

Forest Investigative Site 2041

Minneapolis, Minnesota, United States

Site Status

Forest Investigative Site 1351

Plymouth, Minnesota, United States

Site Status

Forest Investigative Site 1100

Florissant, Missouri, United States

Site Status

Forest Investigative Site 2079

Saint Charles, Missouri, United States

Site Status

Forest Investigative Site 1343

St Louis, Missouri, United States

Site Status

Forest Investigative Site 1329

St Louis, Missouri, United States

Site Status

Forest Investigative Site 1369

St Louis, Missouri, United States

Site Status

Forest Investigative Site 1335

St Louis, Missouri, United States

Site Status

Forest Investigative Site 1367

Papillion, Nebraska, United States

Site Status

Forest Investigative Site 1150

Berlin, New Jersey, United States

Site Status

Forest Investigative Site 1339

Cherry Hill, New Jersey, United States

Site Status

Forest Investigative Site 1515

Elizabeth, New Jersey, United States

Site Status

Forest Investigative Site 1394

Ocean City, New Jersey, United States

Site Status

Forest Investigative Site 2062

Bronxville, New York, United States

Site Status

Forest Investigative Site 1147

Brooklyn, New York, United States

Site Status

Forest Investigative Site 1151

New Hyde Park, New York, United States

Site Status

Forest Investigative Site 1114

New York, New York, United States

Site Status

Forest Investigative Site 1163

New York, New York, United States

Site Status

Forest Investigative Site 1481

Newburgh, New York, United States

Site Status

Forest Investigative Site 0479

Rochester, New York, United States

Site Status

Forest Investigative Site 1368

The Bronx, New York, United States

Site Status

Forest Investigative Site 2081

Charlotte, North Carolina, United States

Site Status

Forest Investigative Site 1334

Charlotte, North Carolina, United States

Site Status

Forest Investigative Site 1366

HighPoint, North Carolina, United States

Site Status

Forest Investigative Site 1382

Statesville, North Carolina, United States

Site Status

Forest Investigative Site 1134

Canton, Ohio, United States

Site Status

Forest Investigative Site 2007

Cincinnati, Ohio, United States

Site Status

Forest Investigative Site 1434

Cleveland, Ohio, United States

Site Status

Forest Investigative Site 1433

Columbus, Ohio, United States

Site Status

Forest Investigative Site 0959

Columbus, Ohio, United States

Site Status

Forest Investigative Site 1505

Columbus, Ohio, United States

Site Status

Forest Investigative Site 1435

Dayton, Ohio, United States

Site Status

Forest Investigative Site 1348

Bend, Oregon, United States

Site Status

Forest Investigative Site 1504

Hershey, Pennsylvania, United States

Site Status

Forest Investigative Site 2072

Charleston, South Carolina, United States

Site Status

Forest Investigative Site 0900

Spartanburg, South Carolina, United States

Site Status

Forest Investigative Site 1365

Rapid City, South Dakota, United States

Site Status

Forest Investigative Site 0962

Nashville, Tennessee, United States

Site Status

Forest Investigative Site 1155

Dallas, Texas, United States

Site Status

Forest Investigative Site 1328

Dallas, Texas, United States

Site Status

Forest Investigative Site 1332

El Paso, Texas, United States

Site Status

Forest Investigative Site 1337

Houston, Texas, United States

Site Status

Forest Investigative Site 1396

San Antonio, Texas, United States

Site Status

Forest Investigative Site 1384

San Antonio, Texas, United States

Site Status

Forest Investigative Site 1330

South Burlington, Vermont, United States

Site Status

Forest Investigative Site 1120

Bellingham, Washington, United States

Site Status

Forest Investigative Site 1531

Tacoma, Washington, United States

Site Status

Forest Investigative Site 2201

Kelowna, British Columbia, Canada

Site Status

Forest Investigative Site 1157

Toronto, Ontario, Canada

Site Status

Forest Investigative Site 1168

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Related Links

Access external resources that provide additional context or updates about the study.

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4068&filename=las-md-35-synopsis.pdf

las-md-35-synopsis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LAS-MD-35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01462929 COMPLETED PHASE3
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
NCT01120093 COMPLETED PHASE2
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00435760 COMPLETED PHASE3
Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
NCT01966107 COMPLETED PHASE4
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00868231 COMPLETED PHASE2
A Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
NCT02153489 COMPLETED PHASE4
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
NCT01049360 COMPLETED PHASE2
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01471171 COMPLETED PHASE3
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
NCT00358436 COMPLETED PHASE3
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01437540 COMPLETED PHASE3
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)
NCT01437397 COMPLETED PHASE3
BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
NCT02375724 COMPLETED PHASE4
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00706914 TERMINATED PHASE2
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT00363896 COMPLETED PHASE3
Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD
NCT02109406 COMPLETED PHASE2
Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
NCT03022097 COMPLETED PHASE3
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01908140 COMPLETED PHASE3
Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate
NCT01078623 COMPLETED PHASE2
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)
NCT01572792 COMPLETED PHASE3
Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination
NCT01462942 COMPLETED PHASE3
Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01636401 COMPLETED PHASE3
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD
NCT02059434 COMPLETED PHASE1
Evaluation of Long-Acting Muscarinic Antagonists in COPD
NCT02039050 COMPLETED PHASE4
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
NCT01425814 COMPLETED PHASE2
1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
NCT00929110 COMPLETED PHASE3