A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00758706

Purpose

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: AZD1236 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-blind, Randomised, Placebo-controlled, Parallel Group Multi-centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Bood and Uine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Period.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Urine and Urination

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Biomarkers in urine, blood and sputum [ Time Frame: As baseline and after 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Nature and incidence of Adverse Events, vital signs and laboratory safety [ Time Frame: Throughout study, assessed at least at inclusion (run-in), randomisation (baseline) and after 1, 2, 4 and 6 weeks of treatment. Also after 1 week follow up. ] [ Designated as safety issue: No ]
Lung Function (Spirometry and PEF)Health status (COPD symptoms, rescue medication use, Clinical COPD questionnaire) [ Time Frame: At inclusion (run-in), randomisation (baseline) and after 1, 2, 4 and 6 weeks of treatment ] [ Designated as safety issue: No ]
Systemic exposure of AZD1236 [ Time Frame: After 2, 4 and 6 weeks of treatment. ] [ Designated as safety issue: No ]

Enrollment:	55
Study Start Date:	September 2008
Study Completion Date:	May 2009

Arms	Assigned Interventions
1: Experimental	Drug: AZD1236 oral tablet, 75 mg, twice daily during 6 weeks
2: Placebo Comparator	Drug: Placebo Dosing to match AZD1236

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of COPD for 1 month
Men or postmenopausal women
Spirometry values indicating symptomatic patients
Smoking history equivalent to using 20 cigarettes a day for 10 years.

Exclusion Criteria:

Any current respiratory tract disorders other than COPD
Requirement for regular oxygen therapy
Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758706

Locations

Denmark
Research Site
ALBORG, Denmark
Research Site
ARHUS C, Denmark
Research Site
KOBENHAVN NV, Denmark
Research Site
ODENSE C, Denmark
Finland
Research Site
HELSINKI, Finland
Research Site
TAMPERE, Finland
Netherlands
Research Site
EINDHOVEN, Netherlands
Research Site
NIEUWEGEIN, Netherlands
Norway
Research Site
OSLO, Norway
Research Site
TRONDHEIM, Norway

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Ronald Dahl, MD, Professor	Arhus Kommune HospitalMedicinsk
Study Director:	Andrew Lockton, MD	AstraZeneca R&D Charnwood

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Andrew Lockton, MD, Medical Science Director, Emerging Products )
Study ID Numbers:	D4260C00007
Study First Received:	September 23, 2008
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00758706 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:

COPD

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 11, 2009