A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
NCT ID: NCT00949975
Last Updated: 2012-08-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
838 participants
INTERVENTIONAL
2009-07-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
AZD9668 active treatment
AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
2
AZD9668 active treatment
AZD9668
2 x 10 mg oral tablets twice daily (bid) for 12 weeks
3
AZD9668 active treatment
AZD9668
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
4
AZD9668 placebo treatment
AZD9668 Placebo
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
AZD9668
2 x 10 mg oral tablets twice daily (bid) for 12 weeks
AZD9668
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
AZD9668 Placebo
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Smokers or ex-smokers
* Males or post-menopausal females between 40 and 80 years old
* Able to use electronic devices
Exclusion Criteria
* Current diagnosis of asthma
* Patients who require long term oxygen therapy
* Treatment with antibiotics within 4 weeks of study visit 1b
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claus Volgemeier, Dr.
Role: PRINCIPAL_INVESTIGATOR
Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Fullerton, California, United States
Research Site
Valparaiso, Indiana, United States
Research Site
Council Bluffs, Iowa, United States
Research Site
Hickory, North Carolina, United States
Research Site
Jefferson Hills, Pennsylvania, United States
Research Site
Gaffney, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Boerne, Texas, United States
Research Site
Concord, New South Wales, Australia
Research Site
Glebe, New South Wales, Australia
Research Site
Kogarah, New South Wales, Australia
Research Site
Carina Heights, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Daw Park, South Australia, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Nedlands, Western Australia, Australia
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Mount Pearl, Newfoundland and Labrador, Canada
Research Site
Antigonish, Nova Scotia, Canada
Research Site
Grimsby, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
La Malbaie, Quebec, Canada
Research Site
Mirabel, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Léonard, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Berlin, , Germany
Research Site
Fulda, , Germany
Research Site
Hanover, , Germany
Research Site
Leipzig, , Germany
Research Site
Marburg, , Germany
Research Site
Seto, Aichi-ken, Japan
Research Site
Noda, Chiba, Japan
Research Site
Touon, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Nihommatsu, Fukushima, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Himeji, Hyōgo, Japan
Research Site
Kagoshima, Kagoshima-ken, Japan
Research Site
Kawasaki, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kochi, Kochi, Japan
Research Site
Ukyo-ku, Kyoto, Kyoto, Japan
Research Site
Matsumoto, Nagano, Japan
Research Site
Saiki, Oita Prefecture, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Kita-ku, Sakai, Osaka, Japan
Research Site
Matsue, Shimane, Japan
Research Site
Chūō, Tokyo, Japan
Research Site
Nakano-ku, Tokyo, Japan
Research Site
Tanabe, Wakayama, Japan
Research Site
Bunkyō City, , Japan
Research Site
Iloilo City, , Philippines
Research Site
Lipa City, Batangas, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Bydgoszcz, , Poland
Research Site
Chęciny, , Poland
Research Site
Krakow, , Poland
Research Site
Ostrów Wielkopolski, , Poland
Research Site
Poznan, , Poland
Research Site
Proszowice, , Poland
Research Site
Tczew, , Poland
Research Site
Wroclaw, , Poland
Research Site
Zawadzkie, , Poland
Research Site
Barnaul, Russia, Russia
Research Site
Kazan', Russia, Russia
Research Site
Moscow, Russia, Russia
Research Site
Novosibirsk, Russia, Russia
Research Site
Saint Petersburg, Russia, Russia
Research Site
Yekaterinburg, Russia, Russia
Research Site
Bardejov, , Slovakia
Research Site
Bojnice, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Nové Mesto nad Váhom, , Slovakia
Research Site
Nové Zámky, , Slovakia
Research Site
Poprad, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Trnava, , Slovakia
Research Site
Zvolen, , Slovakia
Research Site
Žilina, , Slovakia
Research Site
Wŏnju, Gangwon-do, South Korea
Research Site
Uijeongbu-si, Gyeonggi-do, South Korea
Research Site
Anyang, , South Korea
Research Site
Bucheon-si, , South Korea
Research Site
Daegu, , South Korea
Research Site
Seoul, , South Korea
Research Site
Kaohsiung City, , Taiwan
Research Site
Keelung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Research Site
Luhansk, Ukraine, Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
Vogelmeier C, Aquino TO, O'Brien CD, Perrett J, Gunawardena KA. A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium. COPD. 2012 Apr;9(2):111-20. doi: 10.3109/15412555.2011.641803.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D0520C00012
Identifier Type: -
Identifier Source: org_study_id