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Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01908140
Recruitment Status : Completed
First Posted : July 25, 2013
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Aclidinium Bromide / Formoterol Fumarate
Drug: Salmeterol / Fluticasone

  Participant Flow

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 140 activated sites. A total of 121 sites randomised patients. The first patient was screened in Oct 2013 and the last patient visit was in Aug 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients fulfilling inclusion/exclusion criteria at the time of the screening visit were entered into a run-in period of 14-21 days to assess disease stability.

Reporting Groups
  Description
Aclidinium Bromide / Formoterol Fumarate Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
Salmeterol / Fluticasone Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks

Participant Flow:   Overall Study
    Aclidinium Bromide / Formoterol Fumarate   Salmeterol / Fluticasone
STARTED   468   465 
COMPLETED   402   386 
NOT COMPLETED   66   79 
Other or Progressive Disease                5                12 
Lack of Efficacy                7                5 
Withdrawal by Subject                23                24 
Lost to Follow-up                1                6 
Protocol Violation                8                9 
Adverse Event                22                23 



  Baseline Characteristics

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.
Patients with more than 1 treatment were analysed in the Safety population with the actual treatment assigned; for this reason, the Overall Number of Baseline Participants in the safety population is different than the randomised population.

Reporting Groups
  Description
Aclidinium Bromide / Formoterol Fumarate Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
Salmeterol / Fluticasone Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
Total Total of all reporting groups

Baseline Measures
   Aclidinium Bromide / Formoterol Fumarate   Salmeterol / Fluticasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 467   466   933 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
     
Age (years), mean (SD)   63.5  (8.1)   63.3  (7.5)   63.4  (7.8) 
Gender 
[Units: Participants]
     
Female   160   166   326 
Male   307   300   607 
Region of Enrollment 
[Units: Participants]
     
Austria   23   24   47 
Bulgaria   30   32   62 
Canada   12   6   18 
Czech Republic   11   14   25 
France   10   4   14 
Germany   118   136   254 
Hungary   50   48   98 
Italy   6   5   11 
Lithuania   17   10   27 
Netherlands   11   11   22 
Poland   67   55   122 
South Africa   68   66   134 
Spain   28   34   62 
United Kingdom   16   21   37 


  Outcome Measures

1.  Primary:   Peak Forced Expiratory Volume in One Second (FEV1) at Week 24   [ Time Frame: At Week 24 ]

2.  Secondary:   Transition Dyspnoea Index (TDI) Focal Score at Week 24   [ Time Frame: At Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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 Information Center
Organization: AstraZeneca
phone: 1-877-240-9479
e-mail: information.center@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01908140     History of Changes
Other Study ID Numbers: M/40464/39
2013-000116-14 ( EudraCT Number )
First Submitted: July 23, 2013
First Posted: July 25, 2013
Results First Submitted: August 6, 2015
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016