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

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

This study has been completed.

Study NCT00703391. Last updated on November 3, 2008. Information provided by AstraZeneca

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

Primary Outcome Measure ^†

Safety and Tolerability of AZD9668 through the recording and evaluation of adverse events, vital signs, ECG, lung function, haematology, clinical chemistry and urinalysis [ Time Frame: throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ] [ Designated as safety issue: Yes ]
Pharmacokinetic effects of AZD9668 measured in plasma and urine [ Time Frame: Variables measured from pre-dose on day -1 to day 15 (end of dosing) ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Sputum absolute and differential neutrophil count [ Time Frame: Variables will be measured from pre-dose day -1 to post-dose on day 14 ] [ Designated as safety issue: Yes ]
AZD9668 sputum concentrations [ Time Frame: Variables will be measured from pre-dose day -1 to post-dose on day 14 ] [ Designated as safety issue: No ]
Quantitative sputum bacteriology [ Time Frame: Variables will be measured from pre-dose day 1 to post-dose on day 15 ] [ Designated as safety issue: Yes ]

Condition ^†

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^†

Drug: AZD9668
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

June 2008

Completion Date

October 2008

Eligibility 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

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Administrative Information Fields

NCT ID ^†

NCT00703391

Organization ID

D0520C00002

Secondary IDs ^††

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Principal Investigator:

Kristina Panke

Parexel International GmbhH (CRO)

Information Provided By

AstraZeneca

Verification Date

November 2008

First Received Date ^†

June 19, 2008

Last Updated Date

November 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.