This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01437397
First received: September 19, 2011
Last updated: February 2, 2017
Last verified: January 2017
Results First Received: November 16, 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: Aclidinium Bromide
Drug: Formoterol Fumarate
Drug: Placebo

  Participant Flow
  Hide 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 205 sites, 178 in the United States, 9 in Canada, 10 in Australia, and 8 in New Zealand. The first patient was screened in October 2011 and the last patient visit was in February 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 3260 patients were screened for eligibility; 1692 patients were randomized to treatment. A total of 1568 (48.1%) patients screen failed and were discontinued prior to randomization. The primary reason for screening failures was not meeting inclusion/exclusion criteria (41.6%)

Reporting Groups
  Description
Aclidinium/Formoterol 400/12 μg Fixed-dose combination (FDC) administered BID by inhalation
Aclidinium/Formoterol 400/6 μg Fixed-dose combination (FDC) administered BID by inhalation
Aclidinium 400 μg Administered BID by inhalation
Formoterol 12 μg Administered BID by inhalation
Placebo Administered BID by inhalation

Participant Flow:   Overall Study
    Aclidinium/Formoterol 400/12 μg   Aclidinium/Formoterol 400/6 μg   Aclidinium 400 μg   Formoterol 12 μg   Placebo
STARTED   338   338   340   339   337 
COMPLETED   272   276   268   270   236 
NOT COMPLETED   66   62   72   69   101 
Lost to Follow-up                9                4                2                4                5 
Withdrawal by Subject                11                12                24                11                22 
Protocol Violation                10                12                13                21                19 
Lack of Efficacy                5                4                8                10                20 
Adverse Event                21                22                16                14                21 
Site termination/COPD exacerbation/other                10                8                9                9                14 



  Baseline Characteristics
  Hide 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.
Safety population comprising all patients randomized to a treatment group who received at least 1 dose of double-blind investigational treatment.

Reporting Groups
  Description
Aclidinium/Formoterol 400/12 μg Fixed-dose combination (FDC) administered BID by inhalation
Aclidinium/Formoterol 400/6 μg Fixed-dose combination (FDC) administered BID by inhalation
Aclidinium 400 μg Administered BID by inhalation
Formoterol 12 μg Administered BID by inhalation
Placebo Administered BID by inhalation
Total Total of all reporting groups

Baseline Measures
   Aclidinium/Formoterol 400/12 μg   Aclidinium/Formoterol 400/6 μg   Aclidinium 400 μg   Formoterol 12 μg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 335   333   337   332   332   1669 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (8.9)   63.9  (9.2)   64.4  (8.7)   63.7  (8.7)   63.5  (8.9)   63.9  (8.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      167  49.9%      146  43.8%      149  44.2%      163  49.1%      157  47.3%      782  46.9% 
Male      168  50.1%      187  56.2%      188  55.8%      169  50.9%      175  52.7%      887  53.1% 


  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: Week 24 of treatment ]

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

3.  Secondary:   Change in Transition Dyspnea Index (TDI) Focal Score   [ Time Frame: Week 24 of treatment ]

4.  Secondary:   Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: Week 24 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
No text entered.


  More Information
  Hide 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: AstraZeneca Clinical
Organization: Study Information Center
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: NCT01437397     History of Changes
Other Study ID Numbers: LAC-MD-31
Study First Received: September 19, 2011
Results First Received: November 16, 2016
Last Updated: February 2, 2017