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Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01054170
First received: January 20, 2010
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
Results First Received: January 24, 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: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: AZD9668
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
First patient enrolled: 06 January 2010; Last patient completed: 17 November 2010; Twelve centres across 5 countries participated in this study: Canada (2), Denmark (3), The Netherlands (2), Romania (2) and Ukraine (3).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Tiotropium maintenance therapy and reliever medication were commenced at screening, except for patients on inhaled corticosteroids (ICS, ICS/LABA) who were required to stop these at enrolment and commence on tiotropium and reliever medication at the same time. These patients received tiotropium for a period of at least 3 weeks before screening.

Reporting Groups
  Description
AZD9668 AZD9668 2x30mg bid
Placebo Placebo 2 tablets bid

Participant Flow:   Overall Study
    AZD9668     Placebo  
STARTED     25     27  
COMPLETED     21     21  
NOT COMPLETED     4     6  
Protocol Violation                 1                 0  
Withdrawal by Subject                 3                 2  
Adverse Event                 0                 4  



  Baseline Characteristics
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Reporting Groups
  Description
AZD9668 AZD9668 2x30mg bid
Placebo Placebo 2 tablets bid
Total Total of all reporting groups

Baseline Measures
    AZD9668     Placebo     Total  
Number of Participants  
[units: participants]
 		  25     27     52  
Age  
[units: years]
Mean ± Standard Deviation 		  7.2  ± 65     7.7  ± 66     7.45  ± 131  
Gender  
[units: Participants]
 		     
Female     6     10     16  
Male     19     17     36  



  Outcome Measures
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1.  Primary:   AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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2.  Secondary:   5th Generation Wall Area Percentage   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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3.  Secondary:   Air Trapping Index (ATI) on Expiratory Scans   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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4.  Secondary:   Pre-bronchodilator Inspiratory Capacity (IC)   [ Time Frame: Measured after 12 weeks treatment (day 84)      ]
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5.  Secondary:   Pre-bronchodilator Total Lung Capacity (TLC)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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6.  Secondary:   Pre-bronchodilator Functional Residual Capacity (FRC)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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7.  Secondary:   Pre-bronchodilator Residual Volume (RV)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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8.  Secondary:   Pre-bronchodilator Specific Airway Conductance (SGaw)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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9.  Secondary:   Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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10.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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11.  Secondary:   Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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12.  Secondary:   Pre-bronchodilator Forced Vital Capacity (FVC)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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13.  Secondary:   Post-bronchodilator Forced Vital Capacity (FVC)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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14.  Secondary:   Pre-bronchodilator Slow Vital Capacity (SVC)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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15.  Secondary:   Post-bronchodilator Slow Vital Capacity (SVC)   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
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16.  Secondary:   Peak Expiratory Flow (PEF) Morning (Daily Recordings)   [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ]
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17.  Secondary:   Peak Expiratory Flow (PEF) Evening (Daily Recordings)   [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ]
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18.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)   [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ]
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19.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)   [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ]
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20.  Secondary:   Breathlessness, Cough and Sputum Scale (BCSS) Total Score   [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ]
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21.  Secondary:   EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score   [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ]
  Show Outcome Measure 21

22.  Secondary:   St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score   [ Time Frame: Measured after 12 weeks treatment (day 84) ]
  Hide Outcome Measure 22

Measure Type Secondary
Measure Title St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
Measure Description St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).
Time Frame Measured after 12 weeks treatment (day 84)  
Safety Issue No  

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.
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.

Reporting Groups
  Description
AZD9668 AZD9668 2x30mg bid
Placebo Placebo 2 tablets bid

Measured Values
    AZD9668     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  25     23  
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score  
[units: Scores on a scale]
Least Squares Mean ± Standard Error 		  35.64  ± 2.364     39.61  ± 2.389  

No statistical analysis provided for St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score



23.  Secondary:   Percentage of Reliever Free Days in Last Six Weeks of Treatment   [ Time Frame: Average from measurements recorded daily by patient in last 6 weeks of treatment. ]
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24.  Secondary:   Exacerbations   [ Time Frame: Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up) ]
  Show Outcome Measure 24


  Serious Adverse Events
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  Other Adverse Events
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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 NOT 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.


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.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01054170     History of Changes
Other Study ID Numbers: D0520C00014
Study First Received: January 20, 2010
Results First Received: January 24, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Health Canada
Denmark: Danish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: National Medicines Agency
Ukraine: Ministry of Health