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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00629239 |
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: AZD4818 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 4-Week Double-Blind, Placebo-Controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
Estimated Enrollment: | 60 |
Study Start Date: | January 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
AZD4818
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Drug: AZD4818
Dry Powder, inhalation, b.i.d., 4 weeks
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2: Placebo Comparator
Placebo
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Drug: Placebo |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Research Site | |
Hvidovre, Denmark | |
Research Site | |
KØBENHAVN NV, Denmark | |
Research Site | |
ODENSE C, Denmark | |
Finland | |
Research Site | |
TAMPERE, Finland | |
Research Site | |
PREITILÄ, Finland | |
Research Site | |
HELSINKI, Finland | |
Netherlands | |
Research Site | |
BREDA, Netherlands | |
Research Site | |
GRONINGEN, Netherlands | |
Norway | |
Research Site | |
ELVERUM, Norway | |
Research Site | |
OSLO, Norway | |
Research Site | |
TRONDHEIM, Norway | |
Sweden | |
Research Site | |
LUND, Sweden |
Principal Investigator: | Huib AM Kerstjens, MD, PhD | University Medical Centre, Groningen, The Netherlands |
Responsible Party: | AstraZeneca Pharmaceuticals ( Bengt Larsson/MD PhD Medical Science Director ) |
Study ID Numbers: | D3540C00005 |
Study First Received: | February 25, 2008 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00629239 History of Changes |
Health Authority: | Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Netherlands: Medicines Evaluation Board (MEB) |
COPD tolerability inhalation |
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 |