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Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo (LAC-MD-27)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01049360
First received: January 13, 2010
Last updated: January 16, 2017
Last verified: January 2017
Results First Received: September 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Aclidinium 400 μg / Formoterol 12 μg
Drug: Aclidinium 400 μg / Formoterol 6 μg
Drug: Aclidinium 400 μg
Drug: Formoterol 12 μg
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
The study was conducted in a total of 20 study centers in the United States. The first patient was screened in December 2009 and the last patient visit was in August 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sequence 1 Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol
Sequence 2 Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo
Sequence 3 Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6
Sequence 4 Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12
Sequence 5 Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium
Sequence 6 Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12
Sequence 7 Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium
Sequence 8 Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol
Sequence 9 Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo
Sequence 10 Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6
Sequence 11 Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo
Sequence 12 Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6
Sequence 13 Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12
Sequence 14 Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium
Sequence 15 Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol
Sequence 16 Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium
Sequence 17 Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol
Sequence 18 Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo
Sequence 19 Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6
Sequence 20 Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12

Participant Flow for 4 periods

Period 1:   Period 1
    Sequence 1   Sequence 2   Sequence 3   Sequence 4   Sequence 5   Sequence 6   Sequence 7   Sequence 8   Sequence 9   Sequence 10   Sequence 11   Sequence 12   Sequence 13   Sequence 14   Sequence 15   Sequence 16   Sequence 17   Sequence 18   Sequence 19   Sequence 20
STARTED   6   6   7   7   7   6   6   6   7   6   6   6   6   7   7   7   6   6   6   7 
COMPLETED   6   5   7   6   7   6   6   4   5   6   5   6   4   6   7   7   5   6   5   7 
NOT COMPLETED   0   1   0   1   0   0   0   2   2   0   1   0   2   1   0   0   1   0   1   0 
Adverse Event                0                1                0                1                0                0                0                1                0                0                0                0                1                1                0                0                1                0                1                0 
Did not meet inc/exc criteria                0                0                0                0                0                0                0                1                1                0                0                0                0                0                0                0                0                0                0                0 
Withdrawal by Subject                0                0                0                0                0                0                0                0                1                0                1                0                1                0                0                0                0                0                0                0 

Period 2:   Period 2
    Sequence 1   Sequence 2   Sequence 3   Sequence 4   Sequence 5   Sequence 6   Sequence 7   Sequence 8   Sequence 9   Sequence 10   Sequence 11   Sequence 12   Sequence 13   Sequence 14   Sequence 15   Sequence 16   Sequence 17   Sequence 18   Sequence 19   Sequence 20
STARTED   6   5   7   6   7   6   6   4   5   6   5   6   4   6   7   7   5   6   5   7 
COMPLETED   6   4   7   4   7   5   6   4   4   6   5   6   4   6   5   6   5   6   5   5 
NOT COMPLETED   0   1   0   2   0   1   0   0   1   0   0   0   0   0   2   1   0   0   0   2 
Protocol Violation                0                0                0                1                0                0                0                0                0                0                0                0                0                0                1                1                0                0                0                0 
Adverse Event                0                1                0                0                0                0                0                0                1                0                0                0                0                0                0                0                0                0                0                1 
Withdrawal by Subject                0                0                0                1                0                0                0                0                0                0                0                0                0                0                1                0                0                0                0                1 
Lack of Efficacy                0                0                0                0                0                1                0                0                0                0                0                0                0                0                0                0                0                0                0                0 

Period 3:   Period 3
    Sequence 1   Sequence 2   Sequence 3   Sequence 4   Sequence 5   Sequence 6   Sequence 7   Sequence 8   Sequence 9   Sequence 10   Sequence 11   Sequence 12   Sequence 13   Sequence 14   Sequence 15   Sequence 16   Sequence 17   Sequence 18   Sequence 19   Sequence 20
STARTED   6   4   7   4   7   5   6   4   4   6   5   6   4   6   5   6   5   6   5   5 
COMPLETED   6   4   7   4   7   5   6   4   4   6   5   6   4   6   5   6   5   6   5   5 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 

Period 4:   Period 4
    Sequence 1   Sequence 2   Sequence 3   Sequence 4   Sequence 5   Sequence 6   Sequence 7   Sequence 8   Sequence 9   Sequence 10   Sequence 11   Sequence 12   Sequence 13   Sequence 14   Sequence 15   Sequence 16   Sequence 17   Sequence 18   Sequence 19   Sequence 20
STARTED   6   4   7   4   7   5   6   4   4   6   5   6   4   6   5   6   5   6   5   5 
COMPLETED   6   4   7   3   7   5   6   4   4   6   5   6   4   6   5   6   5   5   5   5 
NOT COMPLETED   0   0   0   1   0   0   0   0   0   0   0   0   0   0   0   0   0   1   0   0 
Protocol Violation                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                1                0                0 
Withdrawal by Subject                0                0                0                1                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0 



  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.
No text entered.

Reporting Groups
  Description
Overall Population Safety population defined as all randomized patients who took at least one dose of double-blind investigational product

Baseline Measures
   Overall Population 
Overall Participants Analyzed 
[Units: Participants]
 128 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (8.8) 
Gender 
[Units: Participants]
Count of Participants
 
Female      73  57.0% 
Male      55  43.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)   [ Time Frame: 0 to 12 hours post-dose on Day 14 ]

2.  Secondary:   Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Day 14 ]

3.  Secondary:   Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Day 14 ]


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



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01049360     History of Changes
Other Study ID Numbers: LAC-MD-27
Study First Received: January 13, 2010
Results First Received: September 22, 2016
Last Updated: January 16, 2017