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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01572792
First received: April 4, 2012
Last updated: March 9, 2017
Last verified: February 2017
Results First Received: December 23, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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


Reporting Groups
  Description
Placebo Placebo administered BID by inhalation
Aclidinium/Formoterol 400/12 μg Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium/Formoterol 400/6 μg Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium 400 μg Aclidinium bromide 400 μg administered BID by inhalation
Formoterol 12 μg Formoterol fumurate 12 μg administered BID by inhalation

Participant Flow for 2 periods

Period 1:   Lead-in Study
    Placebo   Aclidinium/Formoterol 400/12 μg   Aclidinium/Formoterol 400/6 μg   Aclidinium 400 μg   Formoterol 12 μg
STARTED   337   338   338   340   339 
COMPLETED   236   272   276   268   270 
NOT COMPLETED   101   66   62   72   69 
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 2:   Extension Study
    Placebo   Aclidinium/Formoterol 400/12 μg   Aclidinium/Formoterol 400/6 μg   Aclidinium 400 μg   Formoterol 12 μg
STARTED   146   184   205   194   192 
COMPLETED   121   155   179   165   160 
NOT COMPLETED   25   29   26   29   32 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
Placebo Placebo administered BID by inhalation
Aclidinium/Formoterol 400/12 μg Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium/Formoterol 400/6 μg Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
Aclidinium 400 μg Aclidinium bromide 400 μg administered BID by inhalation
Formoterol 12 μg Formoterol fumurate 12 μg administered BID by inhalation
Total Total of all reporting groups

Baseline Measures
   Placebo   Aclidinium/Formoterol 400/12 μg   Aclidinium/Formoterol 400/6 μg   Aclidinium 400 μg   Formoterol 12 μg   Total 
Overall Participants Analyzed 
[Units: Participants]
 146   182   204   194   192   918 
Age 
[Units: Years]
Mean (Standard Deviation)
 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 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients to Experience Any Treatment-emergent Adverse Event   [ Time Frame: Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52) ]

2.  Secondary:   Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis   [ Time Frame: Baseline of lead-in study to end of treatment (up to Week 52) ]

3.  Secondary:   Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value   [ Time Frame: Baseline of lead-in study to end of treatment (up to Week 52) ]

4.  Secondary:   Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)   [ Time Frame: Baseline of lead-in study to end of treatment (up to Week 52) ]

5.  Other Pre-specified:   Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]

6.  Other Pre-specified:   Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]

7.  Other Pre-specified:   Transition Dyspnea Index (TDI) Focal Score at End of Study   [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]

8.  Other Pre-specified:   Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: Baseline of lead-in study to Week 52 of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01572792     History of Changes
Other Study ID Numbers: LAC-MD-36
Study First Received: April 4, 2012
Results First Received: December 23, 2016
Last Updated: March 9, 2017