14729-D9831C00002- 1 Month Biopsy Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00766415

Purpose

The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: AZD1981 Drug: Placebo	Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Aggregate pathology score [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
Cell counts [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lung function measurements [ Time Frame: At each clinic visit except follow-up ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: At each clinic visit ] [ Designated as safety issue: Yes ]
Diary card variables (symptoms, PEF)Clinical COPD Questionnaire [ Time Frame: DailyBefore and after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AZD1981: Experimental	Drug: AZD1981 Oral tablet, twice daily, 4 weeks treatment
Placebo: Placebo Comparator	Drug: Placebo Placebo

Eligibility

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

Criteria

Inclusion Criteria:

Men or women 40 years or above
FEV1 between 40 and 80% of predicted normal value post-bronchodilator
Clinical diagnosis of COPD

Exclusion Criteria:

Other clinically relevant disease or disorders
Exacerbation of COPD within 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766415

Contacts

Contact: AstraZeneca Clinical Study, Information

800-236-9933

information.center@astrazeneca.com

Locations

Germany
Research Site	Recruiting
Frieburg, Germany
Research Site	Not yet recruiting
GROßHANSDORF, Germany
Research Site	Not yet recruiting
Hannover, Germany
Research Site	Recruiting
Berlin, Germany
Netherlands
Research Site	Not yet recruiting
Amsterdam, Netherlands
United Kingdom
Research site	Not yet recruiting
SOUTHAMPTON, United Kingdom
Research Site	Not yet recruiting
London, United Kingdom
Research Site	Not yet recruiting
Manchester, United Kingdom
Research Site	Not yet recruiting
NEWCASLTE UPON TYNE, United Kingdom
Research Site	Not yet recruiting
LEICESTER, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Norbert Krug

Fraunhofer Institute

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Christer Hultquist, MD, Medical Science Director, R&D )
Study ID Numbers:	D9831C00002
Study First Received:	October 3, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00766415 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

COPD
Moderate to severe 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 May 07, 2009