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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00766415 |
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 |
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) |
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
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Clinical Study, Information | 800-236-9933 | information.center@astrazeneca.com |
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 |
Principal Investigator: | Norbert Krug | Fraunhofer Institute |
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 |
COPD Moderate to severe COPD |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |