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A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients

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ClinicalTrials.gov Identifier: NCT00703391
Recruitment Status : Completed
First Posted : June 23, 2008
Results First Posted : December 29, 2010
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: AZD9668 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A 2-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Tolerability and Pharmacokinetics of Orally Administered AZD9668 in Patients With COPD
Study Start Date : June 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Active Treatment
 Drug: AZD9668
30mg oral tablets twice daily (bid) for 14 days
Placebo Comparator: 2
Placebo Treatment
 Drug: Placebo
Matched placebo to 30mg oral tablet twice daily (bid) for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Alanine Aminotransferase (ALT) [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    ALT level greater than 3 times the upper limit of normal

  2. Aspartate Aminotransferase (AST) [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    AST level greater than 3 times the upper limit of normal

  3. Creatine Kinase (CK) [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    Change from baseline to Day 14

  4. Total Bilirubin [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    Change from baseline to Day 14

  5. Creatinine [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    Creatinine level greater than the upper limit of normal

  6. Haemoglobin (Hb) [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    Change from baseline to Day 14

  7. Reticulocytes [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    Change from baseline to Day 14

  8. Leucocytes [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    Change from baseline to Day 14

  9. QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method) [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    QTcF interval greater than 450 ms

  10. QTcF [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    QTcF change from baseline greater than 60 ms

  11. FEV1 (Forced Expiratory Volume in the First Second) [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]
    Change from baseline to Day 14

  12. Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12)) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]
    AUC(0-12) following 14 days' dosing

  13. Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]
    Cmax following 14 days' dosing

  14. Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]
    tmax following 14 days' dosing

  15. Terminal Half-life of Drug in Plasma (t1/2) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]
    t1/2 following 14 days' dosing

  16. Renal Clearance of Drug From Plasma (CLR) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]
    CLR following 14 days' dosing


Secondary Outcome Measures :
  1. Sputum Absolute Neutrophil Count [ Time Frame: Pre-dose day -1 to post-dose on day 14 ]
    Change from baseline to Day 14 in absolute neutrophil count

  2. Sputum Differential Neutrophil Count [ Time Frame: Pre-dose day -1 to post-dose on day 14 ]
    Change from baseline to Day 14 in percentage neutrophil count

  3. AZD9668 Sputum Concentrations [ Time Frame: Pre-dose day -1 to post-dose on day 14 ]
  4. Quantitative Sputum Bacteriology [ Time Frame: Pre-dose day -1 to post-dose on day 15 ]
    Number of patients with an increase in bacteriological count from Day -1 to Day 15


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate COPD
  • Smokers or ex-smokers
  • post-menopausal females

Exclusion Criteria:

  • Past history or current evidence of clinically significant heart disease
  • Lung disease other than COPD
  • Treatment with systemic steroids within 8 weeks of study visit 2
  • Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703391


Locations
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Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Kristina Panke Parexel International GmbhH (CRO)
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00703391    
Other Study ID Numbers: D0520C00002
First Posted: June 23, 2008    Key Record Dates
Results First Posted: December 29, 2010
Last Update Posted: January 26, 2012
Last Verified: January 2012
Keywords provided by AstraZeneca:
Chronic
obstructive
pulmonary
lung
respiratory disease
 tolerability
placebo-controlled
pharmacokinetics
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases