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A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00363896
First received: August 10, 2006
Last updated: November 16, 2016
Last verified: November 2016
Results First Received: August 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Aclidinium bromide
Drug: Placebo

  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 in 132 sites: 1 in Andorra, 5 in Austria, 4 in Belgium, 10 in Bulgaria, 8 in the Czech Republic, 3 in Denmark, 9 in France, 10 in Germany, 8 in Hungary, 6 in Italy, 4 in Netherlands, 9 in Poland, 9 in Romania, 25 in Russia, 8 in Spain, 13 in the UK. First patient was screened in Aug 2006 and last patient visit was May 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following a screening visit, patients entered a 14-day run-in period during which they used inhaled salbutamol administered via a pressurised metered dose inhaler (pMDI) as rescue medication on an “as needed” basis. The 14-day run-in period was used to assess the stability of each patient’s disease and baseline characteristics.

Reporting Groups
  Description
Aclidinium Bromide 200 μg Once-daily Aclidinium bromide 200 μg once-daily by inhalation
Placebo Placebo by inhalation

Participant Flow:   Overall Study
    Aclidinium Bromide 200 μg Once-daily   Placebo
STARTED   627   216 
COMPLETED   538   169 
NOT COMPLETED   89   47 
Withdrawal by Subject                29                16 
Adverse Event                24                13 
COPD exacerbation                13                7 
Lack of Efficacy                12                8 
Protocol Violation                6                1 
Lost to Follow-up                3                0 
Non-fulfilment of entry criteria                1                0 
Other                1                2 



  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.
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Reporting Groups
  Description
Aclidinium Bromide 200 μg Once-daily Aclidinium bromide 200 μg once-daily by inhalation
Placebo Placebo by inhalation
Total Total of all reporting groups

Baseline Measures
   Aclidinium Bromide 200 μg Once-daily   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 627   216   843 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      378  60.3%      134  62.0%      512  60.7% 
>=65 years      249  39.7%      82  38.0%      331  39.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.6  (8.2)   61.9  (8.3)   62.4  (8.2) 
Gender 
[Units: Participants]
Count of Participants
     
Female      139  22.2%      41  19.0%      180  21.4% 
Male      488  77.8%      175  81.0%      663  78.6% 
Region of Enrollment 
[Units: Participants]
     
Andorra   3   1   4 
Austria   14   4   18 
Belgium   9   2   11 
Bulgaria   61   20   81 
Czech Republic   43   15   58 
Germany   56   18   74 
Denmark   9   3   12 
Spain   31   10   41 
France   36   14   50 
United Kingdom   46   13   59 
Hungary   39   15   54 
Italy   12   5   17 
Netherlands   17   6   23 
Poland   64   22   86 
Romania   37   13   50 
Russian Federation   150   55   205 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Trough FEV1 (L) at 28 Weeks on Treatment   [ Time Frame: Week 28 ]

2.  Primary:   Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment   [ Time Frame: Week 12 ]

3.  Secondary:   Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment   [ Time Frame: Week 52 ]

4.  Secondary:   Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment   [ Time Frame: 52 weeks ]


  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
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  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: 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: NCT00363896     History of Changes
Other Study ID Numbers: M/34273/30
ACCLAIM I ( Other Identifier: Almirall,S.A. )
CT000740 ( Other Identifier: Almirall,S.A. )
Study First Received: August 10, 2006
Results First Received: August 14, 2012
Last Updated: November 16, 2016