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Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01437540
First received: September 19, 2011
Last updated: April 3, 2017
Last verified: March 2017
Results First Received: December 19, 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 Fumarate
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 at 127 centers in the United States

The first patient was screened in September 2011 and the last patient visit was in March 2013


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

The study consisted of a 2- to 3-week run-in period designed to assess the stability of patients’ disease and establish each patient’s baseline characteristics

1063 patients were screened for eligibility; 473 were considered screen failures (main reason [406/473] inclusion/exclusion criteria not met)


Reporting Groups
  Description
Aclidinium/Formoterol 400 μg/12 μg Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
Formoterol 12 μg Formoterol 12 μg administered BID via dry-powder inhaler

Participant Flow:   Overall Study
    Aclidinium/Formoterol 400 μg/12 μg   Formoterol 12 μg
STARTED   392   198 
COMPLETED   265   133 
NOT COMPLETED   127   65 
Not listed below                7                6 
COPD exacerbation                13                3 
Lost to Follow-up                3                5 
Lack of Efficacy                23                11 
Protocol Violation                24                12 
Adverse Event                26                13 
Withdrawal by Subject                31                15 



  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/Formoterol 400 μg/12 μg Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
Formoterol 12 μg Formoterol 12 μg administered BID via dry-powder inhaler
Total Total of all reporting groups

Baseline Measures
   Aclidinium/Formoterol 400 μg/12 μg   Formoterol 12 μg   Total 
Overall Participants Analyzed 
[Units: Participants]
 392   198   590 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.9  (9.3)   64.7  (9.4)   64.2  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      176  44.9%      89  44.9%      265  44.9% 
Male      216  55.1%      109  55.1%      325  55.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)   [ Time Frame: Up to study Week 56 ± 3 days ]

2.  Secondary:   Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study   [ Time Frame: Up to study Week 52 ]

3.  Secondary:   Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure   [ Time Frame: Up to study Week 56 ± 3 days ]

4.  Secondary:   Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline   [ Time Frame: Up to study Week 56 ± 3 days ]


  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
The objective of the study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol fixed-dose combination (FDC) Therefore there were were no primary and secondary efficacy assessments


  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: NCT01437540     History of Changes
Other Study ID Numbers: LAC-MD-32
Study First Received: September 19, 2011
Results First Received: December 19, 2016
Last Updated: April 3, 2017