Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (Columbus)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690482
First received: May 30, 2008
Last updated: December 13, 2013
Last verified: December 2013
Results First Received: July 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Moderate to Severe COPD
Interventions: Drug: AZD1981
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
118 patients were allocated to treatment and 111 completed the study. First patient entered the study on 26 May 2008 and the last patient finished the study on 17 December 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
AZD1981 AZD1981 Oral tablet, twice daily
Placebo Placebo Oral tablet, twice daily

Participant Flow:   Overall Study
    AZD1981     Placebo  
STARTED     61     57  
COMPLETED     57     54  
NOT COMPLETED     4     3  
Adverse Event                 2                 1  
Incorrect enrolment                 0                 1  
Study-specific discontinuation criteria                 1                 0  
Intake of prohibited medicine                 1                 0  
withdrew consent at rand.day                      0                 1  



  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.
One patient randomised to placebo withdrew consent immediately after the first dose of investigational product on the day of randomisation. No clinical measurements were performed and no reports of AEs were received for this patient. Since the patient is non-informative both in terms of efficacy and safety, he has been excluded from the analyses.

Reporting Groups
  Description
AZD1981 AZD1981 Oral tablet, twice daily
Placebo Placebo Oral tablet, twice daily
Total Total of all reporting groups

Baseline Measures
    AZD1981     Placebo     Total  
Number of Participants  
[units: participants]
  61     56     117  
Age  
[units: Years]
Mean ( Full Range )
  64.1  
  ( 47 to 78 )  
  62.4  
  ( 43 to 83 )  
  62.4  
  ( 43 to 83 )  
Gender  
[units: Participants]
     
Female     12     8     20  
Male     49     48     97  



  Outcome Measures
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1.  Primary:   FEV1   [ Time Frame: Baseline and Week 4 ]

2.  Primary:   Clinical COPD Questionnaire   [ Time Frame: Baseline and Week 4 ]

3.  Secondary:   Forced Vital Capacity   [ Time Frame: Baseline and Week 4 ]

4.  Secondary:   Slow Vital Capacity   [ Time Frame: Baseline and Week 4 ]

5.  Secondary:   Inspiratory Capacity   [ Time Frame: Baseline and Week 4 ]

6.  Secondary:   FEF25%-75%   [ Time Frame: Baseline and Week 4 ]

7.  Secondary:   COPD Symptom Sleep Score   [ Time Frame: Baseline and 4-week treatment period average ]

8.  Secondary:   COPD Symptom Breathing Score   [ Time Frame: Baseline and 4-week treatment period average ]

9.  Secondary:   COPD Symptom Cough Score   [ Time Frame: Baseline and 4-week treatment period average ]

10.  Secondary:   COPD Symptom Sputum Score   [ Time Frame: Baseline and 4-week treatment period average ]

11.  Secondary:   PEF (Peak Expiratory Flow) Morning   [ Time Frame: Baseline and 4-week treatment period average ]

12.  Secondary:   PEF (Peak Expiratory Flow) Evening   [ Time Frame: Baseline and 4-week treatment period average ]

13.  Secondary:   Total Use of Reliever   [ Time Frame: Baseline and 4-week treatment period average ]

14.  Secondary:   Adverse Event   [ Time Frame: Up to 4 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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alison Holt
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00690482     History of Changes
Other Study ID Numbers: D9831C00001
Study First Received: May 30, 2008
Results First Received: July 1, 2013
Last Updated: December 13, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency