14729-D9831C00002- 1 Month Biopsy Study

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00766415

First received: October 3, 2008

Last updated: June 24, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2008

Last Updated Date

June 24, 2009

Start Date ^ICMJE

October 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00766415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

14729-D9831C00002- 1 Month Biopsy Study

Official Title ^ICMJE

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)

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: AZD1981
Oral tablet, twice daily, 4 weeks treatment
Drug: Placebo
Placebo

Study Arm (s)

Experimental: AZD1981
Intervention: Drug: AZD1981
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Netherlands, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00766415

Other Study ID Numbers ^ICMJE

D9831C00002

Has Data Monitoring Committee

Yes

Responsible Party

Christer Hultquist, MD, Medical Science Director, R&D, AstraZeneca Pharmaceuticals

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Norbert Krug

Fraunhofer Institute

Information Provided By

AstraZeneca

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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