Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients (GLAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00929708
First received: June 26, 2009
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: COPD
Interventions: Drug: AZD3199
Drug: formoterol
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 has been performed at 53 centres in Bulgaria, Canada, Japan, Poland and Russian Federation. The recruitment period was between 16 June 2009 and 8 January 2010.

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
AZD3199 200 Mcg od 2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
AZD3199 400 Mcg od 2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
AZD3199 800 Mcg od 2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
Formoterol 9 Mcg Bid 2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
Placebo 2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)

Participant Flow:   Overall Study
    AZD3199 200 Mcg od     AZD3199 400 Mcg od     AZD3199 800 Mcg od     Formoterol 9 Mcg Bid     Placebo  
STARTED     65     69     65     67     63  
COMPLETED     61     66     62     61     57  
NOT COMPLETED     4     3     3     6     6  
Protocol Violation                 2                 1                 1                 1                 1  
Withdrawal by Subject                 2                 0                 0                 2                 1  
Adverse Event                 0                 0                 0                 0                 3  
Physician Decision                 0                 2                 2                 2                 1  
Lost to Follow-up                 0                 0                 0                 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
AZD3199 200 Mcg od 2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
AZD3199 400 Mcg od 2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
AZD3199 800 Mcg od 2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
Formoterol 9 Mcg Bid 2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
Placebo 2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
Total Total of all reporting groups

Baseline Measures
    AZD3199 200 Mcg od     AZD3199 400 Mcg od     AZD3199 800 Mcg od     Formoterol 9 Mcg Bid     Placebo     Total  
Number of Participants  
[units: participants]
  65     69     65     67     63     329  
Age  
[units: Years]
Mean ( Full Range )
  62.4  
  ( 45 to 81 )  
  63.8  
  ( 40 to 82 )  
  65.3  
  ( 41 to 92 )  
  64.1  
  ( 47 to 77 )  
  64.8  
  ( 46 to 84 )  
  63.85  
  ( 62.4 to 65.3 )  
Gender  
[units: participants]
           
Female     18     16     20     16     12     82  
Male     47     53     45     51     51     247  



  Outcome Measures
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1.  Primary:   FEV1, E0−4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)   [ Time Frame: 0,5 min, 15 min, 60 min, 2 h, 4 h ]

2.  Primary:   FEV1, E24−26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)   [ Time Frame: 24h, 26h ]

3.  Secondary:   Cmax; the Highest Plasma Concentration of AZD3199 Measured   [ Time Frame: 0,15 min, 1, 4 and 24 hours post dose ]

4.  Secondary:   AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose   [ Time Frame: 0,15 min, 1, 4 and 24 hours post dose ]

5.  Secondary:   FEV1 Post Salbutamol Inhalation   [ Time Frame: Baseline (visit 2) and 26 h after the last morning dose (visit 5). ]

6.  Secondary:   Total Number of Reliever Medication Inhalations Per 24h   [ Time Frame: During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks. ]

7.  Secondary:   Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)   [ Time Frame: Daily, during run-in and treatment ]

8.  Secondary:   Overall Mean CCQ (Clinical COPD Questionnaire)   [ Time Frame: Mean over week 0, mean over week 1, mean over week 2, and mean over week 4 ]

9.  Secondary:   Total Score SGRQ-C (St George’s Respiratory Questionnaire for COPD)   [ Time Frame: At baseline (visit 2) and after 4 weeks of treatment (visit 5). ]


  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: Carin Jorup, MSD
Organization: AstraZeneca
e-mail: clinicaltrialtransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00929708     History of Changes
Other Study ID Numbers: D0570C00003
Study First Received: June 26, 2009
Results First Received: December 20, 2012
Last Updated: January 22, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation