Chronic Obstructive Pulmonary DiseasePhase 3LAS-MD-35NCT01044459

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

A Phase 3 study testing Aclidinium Bromide 200 µg and Aclidinium Bromide 400 µg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 113 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

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Aclidinium Bromide 200 µg and Aclidinium Bromide 400 µg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 605 participants
Where: 113 sitesin 2 countries
Study dates: Nov 2009to Apr 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, 2010; 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

113 sites in 2 countries.

Country

City, postcode or hospital

113 sites in 2 countries

United States110 sites

Forest Investigative Site 0980
Atlanta, Georgia, 30342
Forest Investigative Site 1491
Atlanta, Georgia, 30342
Forest Investigative Site 0987
Austell, Georgia, 30106
Forest Investigative Site 1436
Avon, Indiana, 46123
Forest Investigative Site 1333
Baltimore, Maryland, 21236
Forest Investigative Site 1120
Bellingham, Washington, 98225
Forest Investigative Site 1348
Bend, Oregon, 97701
Forest Investigative Site 1150
Berlin, New Jersey, 09009
Forest Investigative Site 1162
Birmingham, Alabama, 35209
Forest Investigative Site 1154
Brandon, Florida, 33511
Forest Investigative Site 2062
Bronxville, New York, 10708
Forest Investigative Site 1147
Brooklyn, New York, 11234
Forest Investigative Site 1483
Buena Park, California, 90620
Forest Investigative Site 1134
Canton, Ohio, 44718
Forest Investigative Site 2072
Charleston, South Carolina, 29406
Forest Investigative Site 2081
Charlotte, North Carolina, 28207
Forest Investigative Site 1334
Charlotte, North Carolina, 28226
Forest Investigative Site 1339
Cherry Hill, New Jersey, 08003
Forest Investigative Site 2007
Cincinnati, Ohio, 45231
Forest Investigative Site 1152
Clearwater, Florida, 33765
Forest Investigative Site 1434
Cleveland, Ohio, 44122
Forest Investigative Site 1532
Columbus, Georgia, 31904
Forest Investigative Site 1433
Columbus, Ohio, 43213
Forest Investigative Site 0959
Columbus, Ohio, 43214
Forest Investigative Site 1505
Columbus, Ohio, 43235
Forest Investigative Site 1514
Coral Gables, Florida, 33134
Forest Investigative Site 2085
Crescent Springs, Kentucky, 41017
Forest Investigative Site 1520
Crestview Hills, Kentucky, 41017
Forest Investigative Site 1155
Dallas, Texas, 75231
Forest Investigative Site 1328
Dallas, Texas, 75231
Forest Investigative Site 1435
Dayton, Ohio, 45406
Forest Investigative Site 0670
DeLand, Florida, 32720
Forest Investigative Site 1516
Edgewater, Florida, 32141
Forest Investigative Site 1332
El Paso, Texas, 79903
Forest Investigative Site 1515
Elizabeth, New Jersey, 07202
Forest Investigative Site 1421
Fall River, Massachusetts, 02720
Forest Investigative Site 1100
Florissant, Missouri, 63033
Forest Investigative Site 1350
Foothill Ranch, California, 92610
Forest Investigative Site 2037
Fort Collins, Colorado, 80528
Forest Investigative Site 0990
Fort Lauderdale, Florida, 33316
Forest Investigative Site 1509
Fresno, California, 93720
Forest Investigative Site 2065
Fullerton, California, 92835
Forest Investigative Site 1104
Hartford, Connecticut, 06105
Forest Investigative Site 1504
Hershey, Pennsylvania, 17033
Forest Investigative Site 1513
Hialeah, Florida, 33102
Forest Investigative Site 1366
HighPoint, North Carolina, 27262
Forest Investigative Site 1337
Houston, Texas, 77054
Forest Investigative Site 1502
Huntington Park, California, 90255
Forest Investigative Site 2024
Lafayette, Louisiana, 70503
Forest Investigative Site 1088
Lakewood, California, 90712
Forest Investigative Site 0539
Lexington, Kentucky, 40504
Forest Investigative Site 1534
Long Beach, California, 90813
Forest Investigative Site 2209
Los Angeles, California, 90095
Forest Investigative Site 1336
Louisville, Kentucky, 40215
Forest Investigative Site 1478
Louisville, Kentucky, 40217
Forest Investigative Site 1420
Miami, Florida, 33133
Forest Investigative Site 1432
Miami, Florida, 33143
Forest Investigative Site 2041
Minneapolis, Minnesota, 55402
Forest Investigative Site 1484
Miramar, Florida, 33025
Forest Investigative Site 1127
Mobile, Alabama, 36608
Forest Investigative Site 0962
Nashville, Tennessee, 37232
Forest Investigative Site 1151
New Hyde Park, New York, 11040
Forest Investigative Site 1114
New York, New York, 10010
Forest Investigative Site 1163
New York, New York, 10016
Forest Investigative Site 1346
Newark, Delaware, 19713
Forest Investigative Site 1481
Newburgh, New York, 12550
Forest Investigative Site 1340
Ocala, Florida, 34471
Forest Investigative Site 1394
Ocean City, New Jersey, 07712
Forest Investigative Site 1122
Orange, California, 92868
Forest Investigative Site 1508
Palm Springs, California, 92262
Forest Investigative Site 1367
Papillion, Nebraska, 68046
Forest Investigative Site 1488
Pembroke Pines, Florida, 33027
Forest Investigative Site 0974
Pensacola, Florida, 32504
Forest Investigative Site 1351
Plymouth, Minnesota, 55441
Forest Investigative Site 1397
Port Charlotte, Florida, 33952
Forest Investigative Site 1383
Port Orange, Florida, 32127
Forest Investigative Site 1365
Rapid City, South Dakota, 57702
Forest Investigative Site 2051
River Forest, Illinois, 60305
Forest Investigative Site 2064
Riverside, California, 92506
Forest Investigative Site 0479
Rochester, New York, 14618
Forest Investigative Site 1533
Sacramento, California, 95825
Forest Investigative Site 2079
Saint Charles, Missouri, 63301
Forest Investigative Site 1396
San Antonio, Texas, 78125
Forest Investigative Site 1384
San Antonio, Texas, 78328
Forest Investigative Site 2009
San Diego, California, 92120
Forest Investigative Site 1439
San Diego, California, 92123
Forest Investigative Site 1503
San Diego, California, 92928
Forest Investigative Site 1347
San Jose, California, 95117
Forest Investigative Site 1475
Scottsdale, Arizona, 85258
Forest Investigative Site 0989
Skokie, Illinois, 60076
Forest Investigative Site 1330
South Burlington, Vermont, 05403
Forest Investigative Site 0900
Spartanburg, South Carolina, 29303
Forest Investigative Site 1344
Spring Valley, California, 91978
Forest Investigative Site 1343
St Louis, Missouri, 63128
Forest Investigative Site 1329
St Louis, Missouri, 63141
Forest Investigative Site 1369
St Louis, Missouri, 63141
Forest Investigative Site 1335
St Louis, Missouri, 63143
Forest Investigative Site 1482
Stamford, Connecticut, 06902-3633
Forest Investigative Site 1382
Statesville, North Carolina, 28625
Forest Investigative Site 1342
Stevensville, Michigan, 49127
Forest Investigative Site 1531
Tacoma, Washington, 98405
Forest Investigative Site 2082
Tamarac, Florida, 33321
Forest Investigative Site 2047
Tampa, Florida, 33613
Forest Investigative Site 1338
Tempe, Arizona, 85282
Forest Investigative Site 1368
The Bronx, New York, 10457
Forest Investigative Site 1349
Tucson, Arizona, 85710
Forest Investigative Site 1395
Valrico, Florida, 33596
Forest Investigative Site 2039
Walnut Creek, California, 94598
Forest Investigative Site 1327
Wheat Ridge, Colorado, 80033
Forest Investigative Site 1438
Ypsilanti, Michigan, 48197

Other trials in United States

Canada3 sites

Forest Investigative Site 2201
Kelowna, British Columbia, V1Y 8E7
Forest Investigative Site 1157
Toronto, Ontario, M3H 5S4
Forest Investigative Site 1168
Toronto, Ontario, M5G 1N8

Other trials in Canada

About this study

Official title: A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

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.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Aclidinium Bromide 200 µg, Aclidinium Bromide 400 µg
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 Bromide 200 µgDrug
aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Aclidinium Bromide 400 µgDrug
aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Study groups in NCT01044459
Study group	Role	What they receive
Aclidinium Bromide 200 µg	Experimental	aclidinium bromide, inhaled, 52 weeks of treatment Receives: Drug: Aclidinium Bromide 200 µg
Aclidinium Bromide 400 µg	Experimental	aclidinium bromide, inhaled, 52 weeks of treatment Receives: Drug: Aclidinium Bromide 400 µg

What is being measured

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

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
Measured: From baseline to 52 weeks

Secondary outcomes (1)

Change From Baseline in Peak FEV1
Change From Baseline in Peak FEV1 in liters at Week 52.
Measured: 52 weeks

Timeline

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

Nov 2009Apr 2011

First posted7 Jan 2010 (estimated)
Study startNov 2009
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 605 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01044459
Sponsor's protocol ID: LAS-MD-35
Acronym: LAS-MD-35
Status last verified: Feb 2017
First submitted: 5 Jan 2010
Last updated: 20 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01044459
Acronym / sponsor ID: LAS-MD-35 / LAS-MD-35
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 605 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 7 Jan 2010 (estimated)
Results: Posted 13 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aclidinium Bromide 200 µg	Experimental	Drug: Aclidinium Bromide 200 µgaclidinium bromide, inhaled, 52 weeks of treatment
Aclidinium Bromide 400 µg	Experimental	Drug: Aclidinium Bromide 400 µgaclidinium bromide, inhaled, 52 weeks of treatment

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aclidinium Bromide 200 µgaclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment	Drug	Aclidinium Bromide 200 µg
Aclidinium Bromide 400 µgaclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment	Drug	Aclidinium Bromide 400 µg

Primary outcome

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Time frame: From baseline to 52 weeks
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.

1 secondary outcome

Change From Baseline in Peak FEV1
Time frame: 52 weeks

Results and safety

Results posted to the registry on 13 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aclidinium Bromide 200µg	312	179
Aclidinium Bromide 400µg	293	162

Primary outcome: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)

Time frame: From baseline to 52 weeks. Least squares mean (Standard Error). Unit: L

Measure	Aclidinium Bromide 200µg n = 310	Aclidinium Bromide 400µg n = 290
Value	0.034 (0.015)	0.072 (0.015)

Population analysed: Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aclidinium Bromide 200µg	29 of 311 (9.3%)	60 of 311 (19.3%)	Not reported
Aclidinium Bromide 400µg	29 of 291 (10%)	58 of 291 (19.9%)	Not reported

Limitations and caveats (from the sponsor): Site 1420 randomized 31 patients who were discontinued by 21 Jan 2011 due to significant deviations documented in a letter to the FDA on 07 Jan 2011. No changes to the analyses were prospectively specified in the amended statistical analysis plan.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
las-md-35-synopsisLink provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Esther Garcia, MD study director

AstraZeneca

113 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium Bromide 200 µg and Aclidinium Bromide 400 µg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 113 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 20 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 113 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. 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 13 Sep 2012). 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 Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (time frame: From baseline to 52 weeks). 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 NCT01044459.

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 20 Apr 2017.