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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00703391

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 II

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

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

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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 12, 2012