Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients (CERA)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758459
First received: September 23, 2008
Last updated: July 25, 2011
Last verified: July 2011
Results First Received: July 25, 2011  
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
Interventions: Drug: AZD1236
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
No text entered.

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
AZD1236 AZD1236
Placebo Placebo

Participant Flow:   Overall Study
    AZD1236     Placebo  
STARTED     35     39  
COMPLETED     32     35  
NOT COMPLETED     3     4  
Adverse Event                 3                 2  
Protocol Violation                 0                 1  
Withdrawal by Subject                 0                 1  



  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
AZD1236 AZD1236
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    AZD1236     Placebo     Total  
Number of Participants  
[units: participants]
  35     39     74  
Age  
[units: Year]
Mean ( Full Range )
  61.7  
  ( 48 to 76 )  
  61.7  
  ( 46 to 77 )  
  61.7  
  ( 46 to 77 )  
Gender  
[units: Participants]
     
Female     11     12     23  
Male     24     27     51  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Adverse Events   [ Time Frame: all study visits ]

2.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]

3.  Secondary:   Forced Vital Capacity (FVC)   [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]

4.  Secondary:   Vital Capacity (VC)   [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]

5.  Secondary:   Inspiratory Capacity (IC)   [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]

6.  Secondary:   Forced Expiratory Flow (FEF)25−75%   [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]

7.  Secondary:   Peak Expiratory Flow (PEF) Morning   [ Time Frame: Daily during run-in and treatment ]

8.  Secondary:   Peak Expiratory Flow (PEF) Evening   [ Time Frame: Daily during run-in and treatment      ]

9.  Secondary:   Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total   [ Time Frame: Before treatment and after 1, 2, 4 and 6 weeks of treatment ]

10.  Secondary:   Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness   [ Time Frame: Daily during run-in and treatment      ]

11.  Secondary:   Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness   [ Time Frame: Daily during run-in and treatment      ]

12.  Secondary:   Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score   [ Time Frame: Daily during run-in and treatment      ]

13.  Secondary:   Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings   [ Time Frame: Daily during run-in and treatment      ]

14.  Secondary:   6-minute Walk Test   [ Time Frame: Before treatment and after 6 weeks 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 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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: Andrew Lockton, MD, Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00758459     History of Changes
Other Study ID Numbers: D4260C00003
Study First Received: September 23, 2008
Results First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: Bulgaria: Bulgarian Drug Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control