Pulmonary Disease, Chronic ObstructivePhase 3NCT00500318

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

A Phase 3 study testing Aclidinium Bromide in people with Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 52 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

This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
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: 181 participants
Where: 52 sitesin 2 countries
Study dates: Jul 2007to Sep 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

A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
Current or former cigarette smoker
Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Who cannot join

History of presence of asthma, allergic rhinitis, or atopy
Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
Clinically significant respiratory conditions other than COPD
Chronic use of oxygen therapy >= 15 hours a day

Trial locations and contacts

52 sites in 2 countries.

Country

City, postcode or hospital

52 sites in 2 countries

United States42 sites

Forest Investigative Site 0980
Atlanta, Georgia, 30342
Forest Investigative Site 0991
Atlanta, Georgia, 30342
Forest Investigative Site 0987
Austell, Georgia, 30106
Forest Investigative Site 0898
Baltimore, Maryland, 21224
Forest Investigative Site 0886
Boston, Massachusetts, 02135
Forest Investigative Site 0972
Brooklyn, New York, 11229
Forest Investigative Site 2072
Charleston, South Carolina, 29406
Forest Investigative Site 2081
Charlotte, North Carolina, 28207
Forest Investigative Site 0688
Charlotte, North Carolina, 28262
Forest Investigative Site 2663
Clearwater, Florida, 33756
Forest Investigative Site 1107
Columbia, South Carolina, 29201
Forest Investigative Site 0979
Columbia, South Carolina, 29203
Forest Investigative Site 1082
Dallas, Texas, 75231
Forest Investigative Site 2058
Dallas, Texas, 75246
Forest Investigative Site 0971
Great Neck, New York, 11023
Forest Investigative Site 1078
Greenville, South Carolina, 29615
Forest Investigative Site 1057
Hershey, Pennsylvania, 17033
Forest Investigative Site 0890
Houston, Texas, 77030
Forest Investigative Site 0984
Iowa City, Iowa, 52242
Forest Investigative Site 1030
Jacksonville, Florida, 32224
Forest Investigative Site 2088
Jasper, Alabama, 35501
Forest Investigative Site 0889
Livonia, Michigan, 48152
Forest Investigative Site 0957
Long Beach, California, 90822
Forest Investigative Site 0973
Los Angeles, California, 90073
Forest Investigative Site 0887
Los Angeles, California, 90095-1690
Forest Investigative Site 2008
Marietta, Georgia, 30060
Forest Investigative Site 0977
Midvale, Utah, 84047
Forest Investigative Site 0962
Nashville, Tennessee, 37232-2650
Forest Investigative Site 1114
New York, New York, 10001
Forest Investigative Site 2665
New York, New York, 10010-7436
Forest Investigative Site 1029
North Dartmouth, Massachusetts, 02747
Forest Investigative Site 2071
Omaha, Nebraska, 68198-2465
Forest Investigative Site 0974
Pensacola, Florida, 32504
Forest Investigative Site 0888
Philadelphia, Pennsylvania, 19140
Forest Investigative Site 0909
Phoenix, Arizona, 85006
Forest Investigative Site 0988
Sacramento, California, 95817
Forest Investigative Site 2079
Saint Charles, Missouri, 63301
Forest Investigative Site 0983
Scranton, Pennsylvania, 18509
Forest Investigative Site 0900
Spartanburg, South Carolina, 29303
Forest Investigative Site 0981
Toledo, Ohio, 43614
Forest Investigative Site 1080
Topeka, Kansas, 66606
Forest Investigative Site 0885
Torrance, California, 90502

Other trials in United States

Canada10 sites

Forest Investigative Site 0968
Edmonton, Alberta, T6G 2B7
Forest Investigative Site 0891
Hamilton, Ontario, L8N 3Z5
Forest Investigative Site 0960
Kelowna, British Columbia, V1Y 1E4
Forest Investigative Site 2205
Montreal, Quebec, H4J 1C5
Forest Investigative Site 2204
Ottawa, Ontario, K1Y4E9
Forest Investigative Site 0943
Saskatoon, Saskatchewan, S7N 0W8
Forest Investigative Site 0893
Ste-Foy, Quebec, G1V 4G5
Forest Investigative Site 0905
Vancouver, British Columbia, V5Z 1M9
Forest Investigative Site 0969
Windsor, Ontario, N8X 3V6
Forest Investigative Site 0976
Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Aclidinium Bromide, Placebo
Keywords: Bronchitis, Chronic; Emphysema
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Bronchiolitis Obliterans Syndrome, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aclidinium BromideDrug
Aclidinium Bromide, 200μg. Once daily oral inhalation.
PlaceboDrug
Dose matched placebo, once daily oral inhalation.

Study groups in NCT00500318
Study group	Role	What they receive
Aclidinium	Experimental	Not described Receives: Drug: Aclidinium Bromide
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Exercise Endurance Time (ET)
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
Measured: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Secondary outcomes (4)

Trough Forced Expiratory Volume in 1 Second (FEV1)
Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
Measured: Change from baseline (Visit 4) at Week 6 (Visit 6)
Trough Inspiratory Capacity (IC)
Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).
Measured: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Functional Residual Capacity (FRC)
Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
Measured: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
Measured: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Timeline

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

Jul 2007Sep 2010

First posted12 Jul 2007 (estimated)
Study startJul 2007
Primary completionDec 2008
Study completionSep 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 Pulmonary Disease, Chronic ObstructiveStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00500318
Sponsor's protocol ID: LAS-MD-CL26
Status last verified: Nov 2016
First submitted: 10 Jul 2007
Last updated: 6 Jan 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22.
PubMed 21183326

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
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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)
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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 Pulmonary Disease, Chronic Obstructive 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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD
ClinicalTrials.gov ID: NCT00500318
Acronym / sponsor ID: LAS-MD-CL26
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Bronchitis, Chronic; Emphysema
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Dec 2008 (actual)
Study completion: Sep 2010 (actual)
First posted: 12 Jul 2007 (estimated)
Results: Posted 17 Dec 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aclidinium	Experimental	Drug: Aclidinium Bromide
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (4 listed)

A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
Current or former cigarette smoker
Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Key exclusion criteria (5 listed)

History of presence of asthma, allergic rhinitis, or atopy
Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
Clinically significant respiratory conditions other than COPD
Chronic use of oxygen therapy >= 15 hours a 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 BromideAclidinium Bromide, 200μg. Once daily oral inhalation.	Drug	Aclidinium
PlaceboDose matched placebo, once daily oral inhalation.	Drug	Placebo

Primary outcome

Change From Baseline in Exercise Endurance Time (ET)
Time frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.

4 secondary outcomes

Trough Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Change from baseline (Visit 4) at Week 6 (Visit 6)
Trough Inspiratory Capacity (IC)
Time frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Functional Residual Capacity (FRC)
Time frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
Time frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)

Results and safety

Results posted to the registry on 17 Dec 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	86	81
Placebo	95	78

Primary outcome: Change From Baseline in Exercise Endurance Time (ET)

Time frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6). Least squares mean (Standard Error). Unit: Seconds

Measure	Aclidinium n = 86	Placebo n = 94
Value	129.45 (31.19)	13.01 (30.97)

Aclidinium vs Placebo: Least Square Mean: 116.44 (95% CI 37.280 to 195.610), p = 0.0042, ANCOVA

Population analysed: Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aclidinium	2 of 86 (2.3%)	16 of 86 (18.6%)	Not reported
Placebo	3 of 95 (3.2%)	18 of 95 (18.9%)	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 21183326Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22.

Related trials for Pulmonary Disease, Chronic Obstructive

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)
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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.
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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

52 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 Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 52 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 4 inclusion and 5 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 52 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 17 Dec 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 Exercise Endurance Time (ET) (time frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6)). 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 NCT00500318, 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.