LAC-MD-27: Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01049360
• Collaborator: (none)
• Enrollment: 128
• Locations: 20
• Arms: 5
• Duration (Months): 8
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Aclidinium 400 μg / Formoterol 12 μg; Drug: Aclidinium 400 μg / Formoterol 6 μg; Drug: Aclidinium 400 μg; Drug: Formoterol 12 μg; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aclidinium 400 μg / Formoterol 12 μg Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)	Drug: Aclidinium 400 μg / Formoterol 12 μg; 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.
Experimental: Aclidinium 400 μg / formoterol 6 μg Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)	Drug: Aclidinium 400 μg / Formoterol 6 μg; 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.
Experimental: Aclidinium 400 μg Aclidinium bromide 400 μg administered twice-daily (BID)	Drug: Aclidinium 400 μg; Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
Active Comparator: Formoterol 12 μg Formoterol fumarate 12 μg twice-daily	Drug: Formoterol 12 μg; Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
Placebo Comparator: Placebo Placebo twice-daily	Drug: Placebo; Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) [Day 14]

2. Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1) [Day 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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%).

• 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

Exclusion Criteria:

• 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

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Forest Investigative Site 0909	Glendale	Arizona	United States	85306
2	Forest Investigative Site 2050	Pheonix	Arizona	United States	85006
3	Forest Investigative Site 2029	Rancho Mirage	California	United States	92270
4	Forest Investigative Site 1084	Stockton	California	United States	95207
5	Forest Investigative Site 2045	Wheat Ridge	Colorado	United States	80033
6	Forest Investigative Site 1152	Clearwater	Florida	United States	33765
7	Forest Investigative Site 2053	Tampa	Florida	United States	33603
8	Forest Investigative Site 2047	Tampa	Florida	United States	33613
9	Forest Investigative Site 1431	N. Dartmouth	Massachusetts	United States	02747
10	Forest Investigative Site 2084	Summit	New Jersey	United States	07901
11	Forest Investigative Site 1119	Elmira	New York	United States	14901
12	Forest Investigative Site 2035	Elizabeth city	North Carolina	United States	27909
13	Forest Investigative Site 1153	Raleigh	North Carolina	United States	27607
14	Forest Investigative Site 2028	Cincinnati	Ohio	United States	45242
15	Forest Investigative Site 2043	Medford	Oregon	United States	97504
16	Forest Investigative Site 1106	Portland	Oregon	United States	97213
17	Forest Investigative Site 1089	E. Providence	Rhode Island	United States	02914
18	Forest Investigative Site 1121	Spartanburg	South Carolina	United States	29303
19	Forest Investigative Site 1498	San Antonio	Texas	United States	78215
20	Forest Investigative Site 1129	Waco	Texas	United States	76712

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Esther Garcia, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• lac-md-27-synopsis

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01049360
• Other Study ID Numbers: LAC-MD-27
• First Posted: Jan 14, 2010
• Last Update Posted: Feb 28, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by AstraZeneca: Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Formoterol Fumarate

Study Results

Participant Flow

Recruitment Details	The study was conducted in a total of 20 study centers in the United States. The first patient was screened in December 2009 and the last patient visit was in August 2010.

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6	Sequence 7	Sequence 8	Sequence 9	Sequence 10	Sequence 11	Sequence 12	Sequence 13	Sequence 14	Sequence 15	Sequence 16	Sequence 17	Sequence 18	Sequence 19	Sequence 20
Arm/Group Description	Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol	Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo	Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6	Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12	Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium	Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12	Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium	Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol	Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo	Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6	Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo	Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6	Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12	Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium	Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol	Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium	Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol	Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo	Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6	Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12
Period Title: Period 1
STARTED	6	6	7	7	7	6	6	6	7	6	6	6	6	7	7	7	6	6	6	7
COMPLETED	6	5	7	6	7	6	6	4	5	6	5	6	4	6	7	7	5	6	5	7
NOT COMPLETED	0	1	0	1	0	0	0	2	2	0	1	0	2	1	0	0	1	0	1	0
Period Title: Period 1
STARTED	6	5	7	6	7	6	6	4	5	6	5	6	4	6	7	7	5	6	5	7
COMPLETED	6	4	7	4	7	5	6	4	4	6	5	6	4	6	5	6	5	6	5	5
NOT COMPLETED	0	1	0	2	0	1	0	0	1	0	0	0	0	0	2	1	0	0	0	2
Period Title: Period 1
STARTED	6	4	7	4	7	5	6	4	4	6	5	6	4	6	5	6	5	6	5	5
COMPLETED	6	4	7	4	7	5	6	4	4	6	5	6	4	6	5	6	5	6	5	5
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1
STARTED	6	4	7	4	7	5	6	4	4	6	5	6	4	6	5	6	5	6	5	5
COMPLETED	6	4	7	3	7	5	6	4	4	6	5	6	4	6	5	6	5	5	5	5
NOT COMPLETED	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0

Baseline Characteristics

Arm/Group Title	Overall Population
Arm/Group Description	Safety population defined as all randomized patients who took at least one dose of double-blind investigational product
Overall Participants	128
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.5 (8.8)
Gender (Count of Participants)
Female	73 57%
Male	55 43%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Aclidinium 400 μg / Formoterol 12 μg	Aclidinium 400 μg / Formoterol 6 μg	Aclidinium 400 μg	Formoterol 12 μg	Placebo
Arm/Group Description	Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)	Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)	Aclidinium bromide 400 μg administered twice-daily (BID)	Formoterol fumarate 12 μg twice-daily	Placebo twice-daily
Measure Participants	78	83	82	75	81
Least Squares Mean (Standard Error) [Liters]	0.187 (0.019)	0.189 (0.018)	0.144 (0.018)	0.114 (0.019)	-0.013 (0.018)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aclidinium 400 μg / Formoterol 12 μg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least square mean difference
	Estimated Value	0.200
	Confidence Interval	(2-Sided) 95%; 0.156 to 0.245
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.022
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aclidinium 400 μg / Formoterol 6 μg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate
Method of Estimation	Estimation Parameter	Least square mean difference
	Estimated Value	0.202
	Confidence Interval	(2-Sided) 95%; 0.158 to 0.245
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.022
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Aclidinium 400 μg / Formoterol 12 μg	Aclidinium 400 μg / Formoterol 6 μg	Aclidinium 400 μg	Formoterol 12 μg	Placebo
Arm/Group Description	Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)	Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)	Aclidinium bromide 400 μg administered twice-daily (BID)	Formoterol fumarate 12 μg twice-daily	Placebo twice-daily
Measure Participants	84	90	90	85	88
Least Squares Mean (Standard Error) [Liters]	0.124 (0.018)	0.129 (0.018)	0.080 (0.018)	0.071 (0.018)	-0.008 (0.018)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aclidinium 400 μg / Formoterol 12 μg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate
Method of Estimation	Estimation Parameter	Least square mean difference
	Estimated Value	0.132
	Confidence Interval	(2-Sided) 95%; 0.083 to 0.181
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.025
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aclidinium 400 μg / Formoterol 6 μg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.137
	Confidence Interval	(2-Sided) 95%; 0.088 to 0.185
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.025
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Aclidinium 400 μg / Formoterol 12 μg	Aclidinium 400 μg / Formoterol 6 μg	Aclidinium 400 μg	Formoterol 12 μg	Placebo
Arm/Group Description	Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)	Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)	Aclidinium bromide 400 μg administered twice-daily (BID)	Formoterol fumarate 12 μg twice-daily	Placebo twice-daily
Measure Participants	84	90	90	85	87
Least Squares Mean (Standard Error) [Liters]	0.355 (0.022)	0.348 (0.021)	0.260 (0.021)	0.245 (0.022)	0.073 (0.022)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aclidinium 400 μg / Formoterol 12 μg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.281
	Confidence Interval	(2-Sided) 95%; 0.230 to 0.333
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.026
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aclidinium 400 μg / Formoterol 6 μg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.275
	Confidence Interval	(2-Sided) 95%; 0.224 to 0.325
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.026
	Estimation Comments

Adverse Events

Time Frame	Up to 30 days after the last dose of investigational product, for up to 24 weeks
Arm/Group Title	Aclidinium 400 μg / Formoterol 12 μg		Aclidinium 400 μg / Formoterol 6 μg		Aclidinium 400 μg		Formoterol 12 μg		Placebo
Arm/Group Description	Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)		Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)		Aclidinium bromide 400 μg administered twice-daily (BID)		Formoterol fumarate 12 μg twice-daily		Placebo twice-daily
All Cause Mortality
	Aclidinium 400 μg / Formoterol 12 μg		Aclidinium 400 μg / Formoterol 6 μg		Aclidinium 400 μg		Formoterol 12 μg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Aclidinium 400 μg / Formoterol 12 μg		Aclidinium 400 μg / Formoterol 6 μg		Aclidinium 400 μg		Formoterol 12 μg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/87 (2.3%)		0/91 (0%)		1/94 (1.1%)		1/92 (1.1%)		0/92 (0%)
Cardiac disorders
Coronary artery occlusion	0/87 (0%)		0/91 (0%)		0/94 (0%)		1/92 (1.1%)		0/92 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	1/87 (1.1%)		0/91 (0%)		0/94 (0%)		0/92 (0%)		0/92 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma	0/87 (0%)		0/91 (0%)		1/94 (1.1%)		0/92 (0%)		0/92 (0%)
Renal and urinary disorders
Renal failure acute	1/87 (1.1%)		0/91 (0%)		0/94 (0%)		0/92 (0%)		0/92 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/87 (2.3%)		0/91 (0%)		0/94 (0%)		0/92 (0%)		0/92 (0%)
Other (Not Including Serious) Adverse Events
	Aclidinium 400 μg / Formoterol 12 μg		Aclidinium 400 μg / Formoterol 6 μg		Aclidinium 400 μg		Formoterol 12 μg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/91 (0%)		0/94 (0%)		0/92 (0%)		0/92 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication of the results by the Investigator will be subject to mutual agreement between the investigator and sponsor.