Chronic Obstructive Pulmonary DiseasePhase 3NCT00970268

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)

A Phase 3 study testing Aclidinium bromide in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 83 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 291 participants
Where: 83 sitesin 2 countries
Study dates: Aug 2009to Oct 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completion of a lead-in study (NCT00891462)

Who cannot join

Use or anticipated use of any medication prohibited in this study
Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
QTcB of >500 msec on both the pre-dose and post-dose ECG
Women who are pregnant, intend to become pregnant, or are breast-feeding
A life expectancy of less than 1 year
Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

Trial locations and contacts

83 sites in 2 countries.

Country

City, postcode or hospital

83 sites in 2 countries

United States77 sites

Forest Investigative Site 1130
Asheville, North Carolina, 28801
Forest Investigative Site 1183
Atlanta, Georgia, 30329
Forest Investigative Site 0987
Austell, Georgia, 30106
Forest Investigative Site 1150
Berlin, New Jersey, 08009
Forest Investigative Site 1126
Bethlehem, Pennsylvania, 18020
Forest Investigative Site 2040
Biddeford, Maine, 04005
Forest Investigative Site 1162
Birmingham, Alabama, 35209
Forest Investigative Site 1101
Blue Ridge, Georgia, 30513
Forest Investigative Site 1154
Brandon, Florida, 33511
Forest Investigative Site 1147
Brooklyn, New York, 11234
Forest Investigative Site 2067
Butte, Montana, 59701
Forest Investigative Site 1134
Canton, Ohio, 44718
Forest Investigative Site 1181
Centerville, Ohio, 45459
Forest Investigative Site 2072
Charleston, South Carolina, 29406
Forest Investigative Site 1136
Cincinnati, Ohio, 45227
Forest Investigative Site 2007
Cincinnati, Ohio, 45231
Forest Investigative Site 2028
Cincinnati, Ohio, 45242
Forest Investigative Site 1152
Clearwater, Florida, 33765
Forest Investigative Site 1137
Colorado Springs, Colorado, 80907
Forest Investigative Site 0959
Columbus, Ohio, 43215
Forest Investigative Site 2006
Columbus, Ohio, 43215
Forest Investigative Site 2085
Crescent Springs, Kentucky, 41017
Forest Investigative Site 1155
Dallas, Texas, 75231
Forest Investigative Site 1180
Decatur, Georgia, 30033
Forest Investigative Site 0670
DeLand, Florida, 32720
Forest Investigative Site 1161
Duluth, Georgia, 30096
Forest Investigative Site 1089
East Providence, Rhode Island, 02914
Forest Investigative Site 1128
Edina, Minnesota, 55435
Forest Investigative Site 1119
Elmira, New York, 14901
Forest Investigative Site 2016
Erie, Pennsylvania, 16506
Forest Investigative Site 1100
Florissant, Missouri, 63033
Forest Investigative Site 0990
Fort Lauderdale, Florida, 33316
Forest Investigative Site 2012
Fort Worth, Texas, 76104
Forest Investigative Site 2065
Fullerton, California, 92835
Forest Investigative Site 0909
Glendale, Arizona, 85306
Forest Investigative Site 1078
Greenville, South Carolina, 29615
Forest Investigative Site 2080
Greer, South Carolina, 29651
Forest Investigative Site 1144
Johnston, Rhode Island, 02919
Forest Investigative Site 2024
Lafayette, Louisiana, 70503
Forest Investigative Site 1088
Lakewood, California, 90712
Forest Investigative Site 0539
Lexington, Kentucky, 40504
Forest Investigative Site 2043
Medford, Oregon, 97504
Forest Investigative Site 1167
Melbourne, Florida, 32935
Forest Investigative Site 2041
Minneapolis, Minnesota, 55402
Forest Investigative Site 1124
Minneapolis, Minnesota, 55407
Forest Investigative Site 1127
Mobile, Alabama, 36608
Forest Investigative Site 1151
New Hyde Park, New York, 11040
Forest Investigative Site 1141
New York, New York, 10016
Forest Investigative Site 1163
New York, New York, 10016
Forest Investigative Site 1122
Orange, California, 92868
Forest Investigative Site 1060
Ormond Beach, Florida, 32174
Forest Investigative Site 1169
Papillion, Nebraska, 68406
Forest Investigative Site 0974
Pensacola, Florida, 32504
Forest Investigative Site 2060
Phoenix, Arizona, 85023
Forest Investigative Site 1146
Pittsburgh, Pennsylvania, 15243
Forest Investigative Site 1106
Portland, Oregon, 97213
Forest Investigative Site 2029
Rancho Mirage, California, 92270
Forest Investigative Site 2099
Richmond, Virginia, 23225
Forest Investigative Site 2051
River Forest, Illinois, 60305
Forets Investigative Site 2064
Riverside, California, 92506
Forest Investigative Site 0517
Sacramento, California, 95821
Forest Investigative Site 2079
Saint Charles, Missouri, 63301
Forest Investigative Site 1165
San Antonio, Texas, 78229
Forest Investigative Site 2009
San Diego, California, 92120
Forest Investigative Site 0989
Skokie, Illinois, 60076
Forest Investigative Site 1149
South Bend, Indiana, 46617
Forest Investigative Site 1121
Spartanburg, South Carolina, 29303
Forest Investigative Site 1142
Spokane, Washington, 99204
Forest Investigative Site 2084
Summit, New Jersey, 07901
Forest Investigative Site 0988
Tacoma, Washington, 98405
Forest Investigative Site 2082
Tamarac, Florida, 33321
Forest Investigative Site 2053
Tampa, Florida, 33606
Forest Investigative Site 2047
Tampa, Florida, 33613
Forest Investigative Site 1158
Upland, Pennsylvania, 19013
Forest Investigative Site 1129
Waco, Texas, 76712
Forest Investigative Site 2100
Waterbury, Connecticut, 06708
Forest Investigative Site 1185
Winter Park, Florida, 32789

Other trials in United States

Canada6 sites

Forest Investigative Site 2201
Kelowna, British Columbia, V1Y 8E7
Forest Investigative Site 2200
Niagara Falls, Ontario, L2g 1J4
Forest Investigative Site 1168
Toronto, Ontario, M5G 1N8
Forest Investigative Site 1171
Toronto, Ontario, M5T 3A9
Forest Investigative Site 2203
Toronto, Ontario, M6H 3M2
Forest Investigative Site 1177
Vancouver, British Columbia, V5Z 4E1

Other trials in Canada

About this study

Official title: A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

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

Study groups in NCT00970268
Study group	Role	What they receive
1	Experimental	Aclidinium bromide dose, inhaled, for 52 weeks of treatment Receives: Drug: Aclidinium bromide
2	Experimental	Aclidinium bromide dose, inhaled, for 52 weeks of treatment Receives: Drug: Aclidinium bromide

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 (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1
Measured: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks

Secondary outcomes (1)

Change From Baseline in Peak FEV1
Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).
Measured: 52 weeks

Timeline

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

Aug 2009Oct 2010

First posted2 Sep 2009 (estimated)
Study startAug 2009
Primary completionOct 2010
Study completionOct 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: 291 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00970268
Sponsor's protocol ID: LAS-MD-36
Status last verified: Nov 2016
First submitted: 1 Sep 2009
Last updated: 6 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10. doi: 10.3109/15412555.2013.791809. Epub 2013 May 16.
PubMed 23679347

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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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.
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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
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT00970268
Acronym / sponsor ID: LAS-MD-36
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Chronic Obstructive Pulmonary Disease, 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: 291 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 2 Sep 2009 (estimated)
Results: Posted 14 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
1	Experimental	Drug: Aclidinium bromideAclidinium bromide dose, inhaled, for 52 weeks of treatment
2	Experimental	Drug: Aclidinium bromideAclidinium bromide dose, inhaled, for 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 (1 listed)

Completion of a lead-in study (NCT00891462)

Key exclusion criteria (8 listed)

Use or anticipated use of any medication prohibited in this study
Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
QTcB of >500 msec on both the pre-dose and post-dose ECG
Women who are pregnant, intend to become pregnant, or are breast-feeding

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 bromideAclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment	Drug	1
Aclidinium bromideAclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment	Drug	2

Primary outcome

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Time frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1

1 secondary outcome

Change From Baseline in Peak FEV1
Time frame: 52 weeks

Results and safety

Results posted to the registry on 14 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 200 μg	139	96
Aclidinium Bromide 400 μg	152	103

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

Time frame: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks. Least squares mean (Standard Error). Unit: L

Measure	Placebo - Aclidinium Bromide 200 μg n = 38	Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg n = 76	Placebo - Aclidinium Bromide 400 μg n = 41	Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg n = 91
Value	-0.035 (0.040)	0.069 (0.028)	0.069 (0.037)	0.056 (0.025)

Population analysed: From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Event Reporting occurred from August 2009 to November 2010 at 77 study sites (71 in the United States and 6 additional sites in Canada).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo to Aclidinium Bromide 200 μg	7 of 44 (15.9%)	36 of 44 (81.8%)	Not reported
Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg	13 of 93 (14%)	63 of 93 (67.7%)	Not reported
Placebo to Aclidinium Bromide 400μg	7 of 46 (15.2%)	28 of 46 (60.9%)	Not reported
Aclidinium Bromide 400μg to Aclidinium Bromide 400μg	13 of 106 (12.3%)	64 of 106 (60.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23679347D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10. doi: 10.3109/15412555.2013.791809. Epub 2013 May 16.

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)
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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
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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

83 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 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 83 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 1 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 6 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 83 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 14 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: Change from baseline (visit 2 of lead-in study LAS-MD-33) 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 NCT00970268, 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 6 Jan 2017.