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Aclidinium/Formoterol Fixed Combination Dose Finding Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00626522
First received: February 21, 2008
Last updated: September 27, 2016
Last verified: September 2016
Results First Received: June 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Aclidinium bromide and formoterol
Drug: Aclidinium bromide and formoterol 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

The study was conducted in a total of 81 sites: 21 in Russia, 13 in Poland, 8 in India, 8 in Romania, 6 in Australia, 5 in Taiwan, 5 in the Czech Republic, 5 in New Zealand, 4 in Hungary, 3 in Malaysia and 3 in Slovakia

The first patient was screened in February 2008 and the last patient visit was in November 2008


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

A total of 808 patients were screened and 566 were randomized into the study

Among 242 patients who failed to be randomized, the main reason for screen failure was non-fulfillment of one or more study entry criteria (156 patients), followed by subject’s personal request (32 patients)


Reporting Groups
  Description
Aclidinium 200 μg / Formoterol 6 μg Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
Aclidinium 200 μg / Formoterol 12 μg Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
Aclidinium 200 μg / Formoterol 18 μg Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
Aclidinium 200 μg Aclidinium bromide 200 μg once-daily
Formoterol 12 μg Formoterol fumarate 12 μg once-daily
Placebo Placebo once-daily

Participant Flow:   Overall Study
    Aclidinium 200 μg / Formoterol 6 μg   Aclidinium 200 μg / Formoterol 12 μg   Aclidinium 200 μg / Formoterol 18 μg   Aclidinium 200 μg   Formoterol 12 μg   Placebo
STARTED   121   120   125   76   65   59 
COMPLETED   115   113   117   74   58   57 
NOT COMPLETED   6   7   8   2   7   2 
Protocol Violation                0                0                0                0                1                0 
Adverse Event                2                1                2                0                1                1 
Withdrawal by Subject                2                5                5                0                4                1 
COPD exacerbation                0                0                0                1                1                0 
Lost to Follow-up                0                1                0                0                0                0 
Inconsistent reason reported                1                0                0                0                0                0 
Non-fulfilment of in/exclusion criteria                1                0                1                1                0                0 



  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
Aclidinium 200 μg / Formoterol 6 μg Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
Aclidinium 200 μg / Formoterol 12 μg Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
Aclidinium 200 μg / Formoterol 18 μg Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
Aclidinium 200 μg Aclidinium bromide 200 μg once-daily
Formoterol 12 μg Formoterol fumarate 12 μg once-daily
Placebo Placebo once-daily
Total Total of all reporting groups

Baseline Measures
   Aclidinium 200 μg / Formoterol 6 μg   Aclidinium 200 μg / Formoterol 12 μg   Aclidinium 200 μg / Formoterol 18 μg   Aclidinium 200 μg   Formoterol 12 μg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 121   120   125   76   65   59   566 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.9  (9.0)   63.6  (8.9)   63.9  (8.1)   63.7  (9.3)   64.0  (9.8)   60.7  (7.8)   63.3  (8.8) 
Gender 
[Units: Participants]
             
Female   30   22   29   16   11   15   123 
Male   91   98   96   60   54   44   443 


  Outcome Measures
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1.  Primary:   Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-12 hr   [ Time Frame: Baseline and treatment Week 4 ]

2.  Secondary:   Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline and treatment Week 4 ]

3.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Baseline and treatment Week 4 ]

4.  Secondary:   Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-3 hr   [ Time Frame: Baseline and treatment Week 4 ]

5.  Secondary:   Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-6 hr   [ Time Frame: Baseline and treatment Week 4 ]


  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
No text entered.


  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



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00626522     History of Changes
Other Study ID Numbers: M/273FO/23
2007-004435-30 ( EudraCT Number )
Study First Received: February 21, 2008
Results First Received: June 28, 2016
Last Updated: September 27, 2016
Health Authority: Australia: National Health and Medical Research Council