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

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

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

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

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	18
Study Start Date:	June 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Treatment	Drug: AZD9668 30mg oral tablets twice daily (bid) for 14 days
2: Placebo Comparator 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

Contacts


Contact: Christian Wagener	49-30-3068-53094	christian.wagener@parexel.com

Locations


Germany
	Research Site	Recruiting
	Berlin, Germany

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Kristina Panke	Parexel International GmbhH (CRO)

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Dr.Noel Snell MB FRCP, Medical Science Director, RITA Emerging Project Team )
Study ID Numbers:	D0520C00002
First Received:	June 19, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00703391
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

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Respiration Disorders

Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00703391