Chronic Obstructive Pulmonary DiseasePhase 2LAC-MD-27NCT01049360

Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo

A Phase 2 study testing Aclidinium 400 μg / Formoterol 12 μg, Aclidinium 400 μg / Formoterol 6 μg and Aclidinium 400 μg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Aclidinium 400 μg / Formoterol 12 μg, Aclidinium 400 μg / Formoterol 6 μg and Aclidinium 400 μg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 20 sitesUnited States
Study dates: Dec 2009to Aug 2010
Phase: Phase 2
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form
Be male or female aged 40 to 80 years, inclusive
Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
Be a current or former cigarette smoker with a smoking history of at least 10 pack-years
Have post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.
Have post-albuterol/salbutamol FEV1/FVC values < 70% (ie, 100 × post- albuterol/salbutamol FEV1/FVC < 70%).

Show all 9Show fewer

If female, be at least 1 year postmenopausal or surgically sterile (defined as having a hysterectomy or tubal ligation). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin pregnancy test at screening
Be in good stable health (as judged by the Investigator) other than the COPD, based on medical history, physical examination, ECG, spirometry, and clinical laboratory data evaluations
Have COPD symptoms and FEV1 values at the time of randomization that are stable compared with those at Screening (Visit 1), according to the Investigator's medical judgment

Who cannot join

Have been hospitalized for an acute COPD exacerbation within 3 months before screening
Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).
Have any clinically significant respiratory conditions other than COPD
Have a history or presence of asthma verified from medical records
Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry
Have Stage II hypertension, defined as systolic pressure of 160 and above, and diastolic pressure of 100 and above

Show all 19Show fewer

Chronic use of oxygen therapy ≥ 15 hours a day
Have a history, current diagnosis, or presence of exercise-induced bronchospasm
Have a body mass index ≥ 40 kg/m2
Have participated in an pulmonary rehabilitation program within the previous 3 months
Have clinically significant cardiovascular conditions
Have uncontrolled infection resulting from human immunodeficiency virus and/or active hepatitis
Have symptomatic prostatic hypertrophy and/or bladder neck obstruction.
Have narrow-angle glaucoma
Have a history of hypersensitivity reaction (including report of paradoxical bronchospasm) to inhaled anticholinergics (including aclidinium bromide), β2 adrenergic agonists, or any other inhaled medication or any component thereof
Have a QTcB, as indicated in the centralized reading report, above 470 msec in the resting ECGs performed at Screening (Visit 1) and/or patients who are using medications that may prolong the QT interval
Have clinically relevant abnormalities in the results of clinical laboratory tests, in ECG parameters other than QTc, in results of the physical examination,
Have any concurrent medical condition that, in the judgment of the Investigator, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
Do not maintain regular day/night, waking/sleeping cycles (eg, patients with history of sleep apnea syndrome or any disease related with sleep disturbances such as restless legs syndrome or somnambulism)

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Forest Investigative Site 2028
Cincinnati, Ohio, 45242
Forest Investigative Site 1152
Clearwater, Florida, 33765
Forest Investigative Site 1089
East Providence, Rhode Island, 02914
Forest Investigative Site 2035
Elizabeth City, North Carolina, 27909
Forest Investigative Site 1119
Elmira, New York, 14901
Forest Investigative Site 0909
Glendale, Arizona, 85306
Forest Investigative Site 2043
Medford, Oregon, 97504
Forest Investigative Site 1431
North Dartmouth, Massachusetts, 02747
Forest Investigative Site 2050
Pheonix, Arizona, 85006
Forest Investigative Site 1106
Portland, Oregon, 97213
Forest Investigative Site 1153
Raleigh, North Carolina, 27607
Forest Investigative Site 2029
Rancho Mirage, California, 92270
Forest Investigative Site 1498
San Antonio, Texas, 78215
Forest Investigative Site 1121
Spartanburg, South Carolina, 29303
Forest Investigative Site 1084
Stockton, California, 95207
Forest Investigative Site 2084
Summit, New Jersey, 07901
Forest Investigative Site 2053
Tampa, Florida, 33603
Forest Investigative Site 2047
Tampa, Florida, 33613
Forest Investigative Site 1129
Waco, Texas, 76712
Forest Investigative Site 2045
Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

Official title: Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Aclidinium 400 μg / Formoterol 12 μg, Aclidinium 400 μg / Formoterol 6 μg, Aclidinium 400 μg, Formoterol 12 μg, 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 400 μg / Formoterol 12 μgDrug
Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Aclidinium 400 μg / Formoterol 6 μgDrug
Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Aclidinium 400 μgDrug
Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
Formoterol 12 μgDrug
Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
PlaceboDrug
Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Study groups in NCT01049360
Study group	Role	What they receive
Aclidinium 400 μg / Formoterol 12 μg	Experimental	Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) Receives: Drug: Aclidinium 400 μg / Formoterol 12 μg
Aclidinium 400 μg / formoterol 6 μg	Experimental	Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) Receives: Drug: Aclidinium 400 μg / Formoterol 6 μg
Aclidinium 400 μg	Experimental	Aclidinium bromide 400 μg administered twice-daily (BID) Receives: Drug: Aclidinium 400 μg
Formoterol 12 μg	Active comparator	Formoterol fumarate 12 μg twice-daily Receives: Drug: Formoterol 12 μg
Placebo	Placebo comparator	Placebo twice-daily Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)
Measured: 0 to 12 hours post-dose on Day 14

Secondary outcomes (2)

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Measured: Day 14
Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)
Measured: Day 14

Timeline

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

Dec 2009Aug 2010

First posted14 Jan 2010 (estimated)
Study startDec 2009
Primary completionAug 2010
Study completionAug 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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01049360
Sponsor's protocol ID: LAC-MD-27
Acronym: LAC-MD-27
Status last verified: Jan 2017
First submitted: 13 Jan 2010
Last updated: 28 Feb 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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01049360
Acronym / sponsor ID: LAC-MD-27 / LAC-MD-27
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 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 14 Jan 2010 (estimated)
Results: Posted 9 Nov 2016

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: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Aclidinium 400 μg / Formoterol 12 μg	Experimental	Drug: Aclidinium 400 μg / Formoterol 12 μgAclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
Aclidinium 400 μg / formoterol 6 μg	Experimental	Drug: Aclidinium 400 μg / Formoterol 6 μgAclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
Aclidinium 400 μg	Experimental	Drug: Aclidinium 400 μgAclidinium bromide 400 μg administered twice-daily (BID)
Formoterol 12 μg	Active comparator	Drug: Formoterol 12 μgFormoterol fumarate 12 μg twice-daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo twice-daily

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form
Be male or female aged 40 to 80 years, inclusive
Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of the Global Initiative for Chronic Obstructive Lung Disease (2008)
Be a current or former cigarette smoker with a smoking history of at least 10 pack-years
Have post-albuterol/salbutamol FEV1 values ≥ 30% and < 80% of the predicted value. FEV1 will be measured at the Screening Visit (Visit 1) between 10 and 15 minutes after inhalation of albuterol/salbutamol.

Key exclusion criteria (19 listed)

Have been hospitalized for an acute COPD exacerbation within 3 months before screening
Have any respiratory tract infection (including the upper respiratory tract) or signs of a COPD exacerbation or respiratory infection in the 6 weeks before Screening (Visit 1).
Have any clinically significant respiratory conditions other than COPD
Have a history or presence of asthma verified from medical records
Have used theophylline (including long-acting theophylline) within the previous 3 months before study entry

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 400 μg / Formoterol 12 μgAclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.	Drug	Aclidinium 400 μg / Formoterol 12 μg
Aclidinium 400 μg / Formoterol 6 μgAclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.	Drug	Aclidinium 400 μg / formoterol 6 μg
Aclidinium 400 μgAclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.	Drug	Aclidinium 400 μg
Formoterol 12 μgFormoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.	Drug	Formoterol 12 μg
PlaceboPlacebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.	Drug	Placebo

Primary outcome

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)
Time frame: 0 to 12 hours post-dose on Day 14

2 secondary outcomes

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Time frame: Day 14
Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)
Time frame: Day 14

Results and safety

Results posted to the registry on 9 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	6	6
Sequence 2	6	5
Sequence 3	7	7
Sequence 4	7	6
Sequence 5	7	7
Sequence 6	6	6
Sequence 7	6	6
Sequence 8	6	4
Sequence 9	7	5
Sequence 10	6	6
Sequence 11	6	5
Sequence 12	6	6
Sequence 13	6	4
Sequence 14	7	6
Sequence 15	7	7
Sequence 16	7	7
Sequence 17	6	5
Sequence 18	6	6
Sequence 19	6	5
Sequence 20	7	7

Primary outcome: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)

Time frame: 0 to 12 hours post-dose on Day 14. Least squares mean (Standard Error). Unit: Liters

Measure	Aclidinium 400 μg / Formoterol 12 μg n = 78	Aclidinium 400 μg / Formoterol 6 μg n = 83	Aclidinium 400 μg n = 82	Formoterol 12 μg n = 75	Placebo n = 81
Value	0.187 (0.019)	0.189 (0.018)	0.144 (0.018)	0.114 (0.019)	-0.013 (0.018)

Aclidinium 400 μg / Formoterol 12 μg vs Placebo: Least square mean difference: 0.200 (95% CI 0.156 to 0.245), p <0.0001, Mixed Models Analysis
Aclidinium 400 μg / Formoterol 6 μg vs Placebo: Least square mean difference: 0.202 (95% CI 0.158 to 0.245), p <0.0001, Mixed Models Analysis

Population analysed: ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days after the last dose of investigational product, for up to 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aclidinium 400 μg / Formoterol 12 μg	2 of 87 (2.3%)	0 of 87 (0%)	Not reported
Aclidinium 400 μg / Formoterol 6 μg	0 of 91 (0%)	0 of 91 (0%)	Not reported
Aclidinium 400 μg	1 of 94 (1.1%)	0 of 94 (0%)	Not reported
Formoterol 12 μg	1 of 92 (1.1%)	0 of 92 (0%)	Not reported
Placebo	0 of 92 (0%)	0 of 92 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
lac-md-27-synopsisLink provided by the sponsor.

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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

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 19 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Nov 2016). 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 Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12) (time frame: 0 to 12 hours post-dose on Day 14). 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 NCT01049360.

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 28 Feb 2017.