Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: June 28, 2016
Last verified: June 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
  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 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
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

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
  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
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  
Number of Participants  
[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
  Show All Outcome Measures

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: Treatment Week 4 ]

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

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


  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: 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: June 28, 2016
Health Authority: Australia: National Health and Medical Research Council