Skip to main content
OpenTrials
Completed

NCT Number: NCT00703391

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9668

Drug

30mg oral tablets twice daily (bid) for 14 days

Placebo

Drug

Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 23, 2008
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.