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Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01572792
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Drug: Aclidinium bromide
Drug: Formoterol Fumarate
Drug: Placebo
Enrollment 921
Recruitment Details This study was conducted at 169 study centers, 160 in the United States, and 9 in Canada. The first patient was screened in April 2012 and the last patient visit was in June 2013
Pre-assignment Details

This was a double-blind, placebo- and active-controlled, 28-week treatment, extension study of the lead-in study, Study LAC-MD-31

Those patients who chose to continue the treatment in the extension study and met the eligibility for the extension study remained on the same treatment as they were randomized to in the lead-in study

Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description Placebo administered BID by inhalation Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation Aclidinium bromide 400 μg administered BID by inhalation Formoterol fumurate 12 μg administered BID by inhalation
Period Title: Lead-in Study
Started 337 338 338 340 339
Completed 236 272 276 268 270
Not Completed 101 66 62 72 69
Reason Not Completed
Lost to Follow-up             5             9             4             2             4
Withdrawal by Subject             22             11             12             24             11
Protocol Violation             19             10             12             13             21
Lack of Efficacy             20             5             4             8             10
Adverse Event             21             21             22             16             14
Site termination/COPD exacerbation/other             14             10             8             9             9
Period Title: Extension Study
Started 146 184 205 194 192
Completed 121 155 179 165 160
Not Completed 25 29 26 29 32
Reason Not Completed
Lost to Follow-up             6             2             0             3             3
Withdrawal by Subject             7             6             11             8             14
Protocol Violation             0             4             3             4             3
Lack of Efficacy             2             3             3             2             2
Adverse Event             7             6             5             6             4
Site termination/COPD exacerbation/other             3             8             4             6             6
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg Total
Hide Arm/Group Description Placebo administered BID by inhalation Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation Aclidinium bromide 400 μg administered BID by inhalation Formoterol fumurate 12 μg administered BID by inhalation Total of all reporting groups
Overall Number of Baseline Participants 146 182 204 194 192 918
Hide Baseline Analysis Population Description
The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants 182 participants 204 participants 194 participants 192 participants 918 participants
63.2  (8.6) 63.7  (9.1) 63.6  (9.2) 62.9  (8.3) 62.8  (8.7) 63.2  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 182 participants 204 participants 194 participants 192 participants 918 participants
Female
65
  44.5%
94
  51.6%
84
  41.2%
90
  46.4%
102
  53.1%
435
  47.4%
Male
81
  55.5%
88
  48.4%
120
  58.8%
104
  53.6%
90
  46.9%
483
  52.6%
1.Primary Outcome
Title Percentage of Patients to Experience Any Treatment-emergent Adverse Event
Hide Description For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study
Time Frame Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study
Arm/Group Title Placebo Aclidinium/Formmoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 146 182 204 194 192
Measure Type: Number
Unit of Measure: Percentage of participants
56.8 65.9 61.3 67.5 64.6
2.Secondary Outcome
Title Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis
Hide Description

Potentially clinically significant change:

>1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid <0.85 x lower limit of normal (LLN) or > 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH <0.95 x LLN or >1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity >1.1 × ULN

The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study

Time Frame Baseline of lead-in study to end of treatment (up to Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study
Arm/Group Title Placebo Aclidinium/Formmoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 146 182 204 194 192
Measure Type: Number
Unit of Measure: Percentage of participants
32.9 41.2 35.3 32.5 38.5
3.Secondary Outcome
Title Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value
Hide Description [Not Specified]
Time Frame Baseline of lead-in study to end of treatment (up to Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study
Arm/Group Title Placebo Aclidinium/Formmoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 146 182 204 194 192
Measure Type: Number
Unit of Measure: Percentage of participants
QT interval change from baseline >30 msec 53.4 53.8 55.9 60.4 48.4
QT interval >480 msec 3.4 3.8 2.9 2.6 4.7
QTcB change from baseline >30 msec 36.3 37.0 39.7 35.6 38.4
QTcB >480 msec 7.5 8.3 9.8 5.7 8.4
QTcF change from baseline >30 msec 27.4 28.7 30.4 27.8 30.2
QTcF >480 msec 2.1 0.6 1.0 0.5 2.6
QRS interval ≥100 msec & ≥25% increase 6.2 6.6 3.9 2.6 4.7
PR interval ≥200 msec & ≥25% increase 2.8 2.2 1.0 3.1 1.6
Heart rate ≥110 bpm & ≥15% increase from baseline 0.7 2.7 1.0 1.0 2.1
Heart rate ≤50 bpm & ≥15% decrease from baseline 11.0 6.0 8.3 7.2 4.7
4.Secondary Outcome
Title Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)
Hide Description

Potentially clinically significant change:

Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline Pulse rate ≥110 bpm and increase ≥15% from baseline or ≤50 bpm and decrease ≥15% from baseline Weight increase or decrease ≥7% from baseline

The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study

Time Frame Baseline of lead-in study to end of treatment (up to Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study
Arm/Group Title Placebo Aclidinium/Formmoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 146 182 204 194 192
Measure Type: Number
Unit of Measure: Percentage of participants
27.4 24.2 18.6 22.2 24.5
5.Other Pre-specified Outcome
Title Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)
Hide Description [Not Specified]
Time Frame Baseline of lead-in study to Week 52 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 331 335 333 337 332
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.086  (0.017) 0.198  (0.015) 0.166  (0.015) 0.112  (0.015) 0.109  (0.015)
6.Other Pre-specified Outcome
Title Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)
Hide Description [Not Specified]
Time Frame Baseline of lead-in study to Week 52 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 331 335 333 337 332
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.101  (0.017) 0.038  (0.015) 0.005  (0.015) 0.030  (0.015) 0.004  (0.015)
7.Other Pre-specified Outcome
Title Transition Dyspnea Index (TDI) Focal Score at End of Study
Hide Description The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate "no change". The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9.
Time Frame Baseline of lead-in study to Week 52 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 331 335 333 337 332
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
0.731  (0.277) 1.812  (0.251) 1.742  (0.235) 1.596  (0.241) 1.324  (0.246)
8.Other Pre-specified Outcome
Title Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Hide Description St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).
Time Frame Baseline of lead-in study to Week 52 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Placebo administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium bromide 400 μg administered BID by inhalation
Formoterol fumurate 12 μg administered BID by inhalation
Overall Number of Participants Analyzed 331 335 333 337 332
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.862  (0.945) -3.646  (0.861) -5.527  (0.819) -4.306  (0.847) -4.059  (0.853)
Time Frame Follow-up call 14±3 days after end of treatment (Week 28±5 days)
Adverse Event Reporting Description The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study
 
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description Placebo administered BID by inhalation Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation Aclidinium bromide 400 μg administered BID by inhalation Formoterol fumurate 12 μg administered BID by inhalation
All-Cause Mortality
Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/146 (6.85%)   14/182 (7.69%)   14/204 (6.86%)   15/194 (7.73%)   14/192 (7.29%) 
Blood and lymphatic system disorders           
Anaemia  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Haemorrhagic anaemia  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Pancytopenia  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Cardiac disorders           
Atrioventricular block second degree  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Palpitations  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Coronary artery disease  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Acute myocardial infarction  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Angina pectoris  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Myocardial infarction  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  2/194 (1.03%)  1/192 (0.52%) 
Pericardial effusion  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Arrhythmia  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Atrial fibrillation  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Sick sinus syndrome  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Cardiac arrest  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Cardio-respiratory arrest  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Gastrointestinal disorders           
Colitis ulcerative  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Gastritis  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Constipation  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Enterocolitis  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Gastrointestinal haemorrhage  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
General disorders           
Asthenia  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Death  1  1/146 (0.68%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Drug withdrawal syndrome  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Infections and infestations           
Diverticulitis  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  2/192 (1.04%) 
Cellulitis  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  2/192 (1.04%) 
Postoperative wound infection  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Device related infection  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Influenza  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Lobar pneumonia  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  1/194 (0.52%)  0/192 (0.00%) 
Pneumonia  1  0/146 (0.00%)  0/182 (0.00%)  3/204 (1.47%)  2/194 (1.03%)  0/192 (0.00%) 
Sepsis  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  1/194 (0.52%)  0/192 (0.00%) 
Urinary tract infection  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Pneumonia viral  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Bronchitis viral  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Injury, poisoning and procedural complications           
Fibula fracture  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Hip fracture  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Tibia fracture  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Post laminectomy syndrome  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Fall  1  0/146 (0.00%)  1/182 (0.55%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Accidental overdose  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Pelvic fracture  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Ulna fracture  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Investigations           
International normalised ratio increased  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Electrocardiogram abnormal  1  1/146 (0.68%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Metabolism and nutrition disorders           
Diabetes mellitus  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Hypoglycaemia  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Hyponatraemia  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Hypovolaemia  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Dehydration  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Musculoskeletal pain  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Osteoarthritis  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Lumbar spinal stenosis  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Bladder transitional cell carcinoma  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Lung adenocarcinoma  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Metastatic renal cell carcinoma  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Transitional cell carcinoma  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Nervous system disorders           
Cerebrovascular accident  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  2/194 (1.03%)  0/192 (0.00%) 
Carotid artery stenosis  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Cervical myelopathy  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Ataxia  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Syncope  1  1/146 (0.68%)  0/182 (0.00%)  2/204 (0.98%)  0/194 (0.00%)  1/192 (0.52%) 
Convulsion  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Psychiatric disorders           
Anxiety  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Affective disorder  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Renal and urinary disorders           
Renal failure acute  1  0/146 (0.00%)  0/182 (0.00%)  0/204 (0.00%)  1/194 (0.52%)  0/192 (0.00%) 
Nephrolithiasis  1  0/146 (0.00%)  0/182 (0.00%)  1/204 (0.49%)  0/194 (0.00%)  0/192 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  1  0/146 (0.00%)  0/182 (0.00%)  2/204 (0.98%)  1/194 (0.52%)  1/192 (0.52%) 
Pulmonary mass  1  0/146 (0.00%)  2/182 (1.10%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Peripheral vascular disorder  1  0/146 (0.00%)  1/182 (0.55%)  0/204 (0.00%)  0/194 (0.00%)  0/192 (0.00%) 
Hypertension  1  1/146 (0.68%)  0/182 (0.00%)  0/204 (0.00%)  0/194 (0.00%)  1/192 (0.52%) 
Hypotension  1  0/146 (0.00%)  0/182 (0.00%)  2/204 (0.98%)  0/194 (0.00%)  1/192 (0.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/146 (25.34%)   59/182 (32.42%)   64/204 (31.37%)   67/194 (34.54%)   62/192 (32.29%) 
Infections and infestations           
Nasopharyngitis  1  7/146 (4.79%)  14/182 (7.69%)  14/204 (6.86%)  18/194 (9.28%)  13/192 (6.77%) 
Urinary tract infection  1  8/146 (5.48%)  15/182 (8.24%)  13/204 (6.37%)  8/194 (4.12%)  11/192 (5.73%) 
Upper respiratory tract infection  1  8/146 (5.48%)  5/182 (2.75%)  8/204 (3.92%)  9/194 (4.64%)  8/192 (4.17%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  3/146 (2.05%)  5/182 (2.75%)  6/204 (2.94%)  12/194 (6.19%)  5/192 (2.60%) 
Chronic obstructive pulmonary disease  1  23/146 (15.75%)  37/182 (20.33%)  45/204 (22.06%)  44/194 (22.68%)  46/192 (23.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 16.0
The objective of this extension study was to assess long-term safety and tolerability. Thus efficacy assessments were considered only supportive to the lead-in study (LAC-MD-31), and were not categorized as primary, secondary, or additional
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of the results by the Principal Investigator (PI) will be subject to mutual agreement between the PI and the sponsor
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01572792    
Other Study ID Numbers: LAC-MD-36
First Submitted: April 4, 2012
First Posted: April 6, 2012
Results First Submitted: December 23, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017