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Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (TOP)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00629239
First received: February 25, 2008
Last updated: November 4, 2010
Last verified: November 2010
Results First Received: November 4, 2010  
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: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: AZD4818
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
One participant was excluded in the analysis sets since this participat is non-informative both in terms of efficacy and safety, and was immediately withdrawn for non-treatment related reasons. AZD4818 Turbuhaler group will include 33 patients in all other sections

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
AZD4818 AZD4818 Turbuhaler
Placebo Placebo

Participant Flow:   Overall Study
    AZD4818     Placebo  
STARTED     34     32  
COMPLETED     26     28  
NOT COMPLETED     8     4  
Adverse Event                 7                 4  
Physician Decision                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
AZD4818 AZD4818 Turbuhaler
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    AZD4818     Placebo     Total  
Number of Participants  
[units: participants]
  33     32     65  
Age  
[units: years]
Mean ( Full Range )
  65  
  ( 51 to 78 )  
  66  
  ( 42 to 77 )  
  65  
  ( 42 to 78 )  
Gender  
[units: Participants]
     
Female     10     8     18  
Male     23     24     47  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Experiencing Adverse Events   [ Time Frame: At all study visits ]

2.  Secondary:   Forced Expiratory Volume 1 (FEV1)   [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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

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

5.  Secondary:   Inspiratory Capacity (IC)   [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

6.  Secondary:   Forced Expiratory Flow (FEF) 25%-75%   [ Time Frame: Before treatment and after 1, 2, 3 and 4 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:   The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total   [ Time Frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment ]

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

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

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

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

14.  Secondary:   6-minute Walk Test   [ Time Frame: Before treatment and after 4 weeks of treatment ]


  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 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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: Bengt Larsson/MD PhD Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00629239     History of Changes
Other Study ID Numbers: D3540C00005
Study First Received: February 25, 2008
Results First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)