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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00703391
First received: June 19, 2008
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: AZD9668
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

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

  • Total Bilirubin [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
    Change from baseline to Day 14

  • Creatinine [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
    Creatinine level greater than the upper limit of normal

  • Haemoglobin (Hb) [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
    Change from baseline to Day 14

  • Reticulocytes [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
    Change from baseline to Day 14

  • Leucocytes [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
    Change from baseline to Day 14

  • 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) ] [ Designated as safety issue: Yes ]
    QTcF interval greater than 450 ms

  • QTcF [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
    QTcF change from baseline greater than 60 ms

  • 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) ] [ Designated as safety issue: Yes ]
    Change from baseline to Day 14

  • 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) ] [ Designated as safety issue: No ]
    AUC(0-12) following 14 days' dosing

  • Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ] [ Designated as safety issue: No ]
    Cmax following 14 days' dosing

  • 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) ] [ Designated as safety issue: No ]
    tmax following 14 days' dosing

  • Terminal Half-life of Drug in Plasma (t1/2) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ] [ Designated as safety issue: No ]
    t1/2 following 14 days' dosing

  • Renal Clearance of Drug From Plasma (CLR) [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ] [ Designated as safety issue: No ]
    CLR following 14 days' dosing


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

  • Sputum Differential Neutrophil Count [ Time Frame: Pre-dose day -1 to post-dose on day 14 ] [ Designated as safety issue: Yes ]
    Change from baseline to Day 14 in percentage neutrophil count

  • AZD9668 Sputum Concentrations [ Time Frame: Pre-dose day -1 to post-dose on day 14 ] [ Designated as safety issue: No ]
  • Quantitative Sputum Bacteriology [ Time Frame: Pre-dose day -1 to post-dose on day 15 ] [ Designated as safety issue: Yes ]
    Number of patients with an increase in bacteriological count from Day -1 to Day 15


Enrollment: 18
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703391

Locations
Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Kristina Panke Parexel International GmbhH (CRO)
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00703391     History of Changes
Other Study ID Numbers: D0520C00002
Study First Received: June 19, 2008
Results First Received: November 30, 2010
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Chronic
obstructive
pulmonary
lung
respiratory disease
tolerability
placebo-controlled
pharmacokinetics
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014