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Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01462942
First received: October 26, 2011
Last updated: December 22, 2016
Last verified: December 2016
Results First Received: September 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate
Drug: Aclidinium Bromide
Drug: Placebo
Drug: Formoterol Fumarate

  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
The study was conducted in 22 countries (Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, the Netherlands, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Ukraine and UK). The first patient was screened in October 2011 and the last patient visit was in January 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 2443 patients were screened, of whom 1729 were considered eligible and were randomized into the study. 714/2443 patients were not randomized due to screening failure (primarily for non-fulfillment of inclusion/exclusion criteria)

Reporting Groups
  Description
Placebo Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Aclidinium/Formoterol 400/12 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Aclidinium/Formoterol 400/6 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Aclidinium 400 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Formoterol 12 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)

Participant Flow:   Overall Study
    Placebo   Aclidinium/Formoterol 400/12 μg   Aclidinium/Formoterol 400/6 μg   Aclidinium 400 μg   Formoterol 12 μg
STARTED   194   385   381   385   384 
COMPLETED   160   351   341   335   339 
NOT COMPLETED   34   34   40   50   45 
Adverse Event                7                12                10                11                11 
Other, including COPD exacerbation                3                5                2                8                5 
Withdrawal by Subject                14                10                14                16                19 
Lack of Efficacy                6                0                4                5                3 
Lost to Follow-up                0                1                1                1                1 
Protocol Violation                4                6                9                9                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.
No text entered.

Reporting Groups
  Description
Placebo Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Aclidinium/Formoterol 400/12 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Aclidinium/Formoterol 400/6 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Aclidinium 400 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Formoterol 12 μg Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
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]
 194   385   381   385   384   1729 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (8.0)   62.7  (8.1)   62.9  (7.7)   63.1  (8.2)   63.4  (7.8)   63.2  (8.0) 
Gender 
[Units: Participants]
Count of Participants
           
Female      56  28.9%      124  32.2%      122  32.0%      129  33.5%      129  33.6%      560  32.4% 
Male      138  71.1%      261  67.8%      259  68.0%      256  66.5%      255  66.4%      1169  67.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:   Change in Transition Dyspnoea Index (TDI) Focal Score   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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: Esther Garcia
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01462942     History of Changes
Other Study ID Numbers: M/40464/30
Study First Received: October 26, 2011
Results First Received: September 14, 2016
Last Updated: December 22, 2016