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
A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multinational, Phase IIb Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
1 other identifier
interventional
838
12 countries
105
Brief Summary
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Jul 2009
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
August 3, 2012
CompletedAugust 3, 2012
June 1, 2012
1.1 years
July 21, 2009
January 24, 2012
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline Pre-bronchodilator FEV1 (L)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Day 1
End-value Pre-bronchodilator FEV1 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary Outcomes (26)
Post-bronchodilator FEV1 (L) - Baseline
Day 1
Post-bronchodilator FEV1 (L) - End-value
Measured at clinic visits: 1, 4, 8 and 12 weeks
Pre-bronchodilator FVC (L) - Baseline
Day 1
Pre-bronchodilator FVC (L) - End-value
Measured at clinic visits: 1, 4, 8 and 12 weeks
Post-bronchodilator FVC (L) - Baseline
Day 1
- +21 more secondary outcomes
Study Arms (4)
1
ACTIVE COMPARATORAZD9668 active treatment
2
ACTIVE COMPARATORAZD9668 active treatment
3
ACTIVE COMPARATORAZD9668 active treatment
4
PLACEBO COMPARATORAZD9668 placebo treatment
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD with symptoms over 1 year
- Smokers or ex-smokers
- Males or post-menopausal females between 40 and 80 years old
- Able to use electronic devices
You may not qualify if:
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Treatment with antibiotics within 4 weeks of study visit 1b
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (105)
Research Site
Fullerton, California, United States
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Valparaiso, Indiana, United States
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Council Bluffs, Iowa, United States
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Hickory, North Carolina, United States
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Jefferson Hills, Pennsylvania, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Boerne, Texas, United States
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Concord, New South Wales, Australia
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Glebe, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Carina Heights, Queensland, Australia
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Adelaide, South Australia, Australia
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Daw Park, South Australia, Australia
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Parkville, Victoria, Australia
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Nedlands, Western Australia, Australia
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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Antigonish, Nova Scotia, Canada
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Grimsby, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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La Malbaie, Quebec, Canada
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Mirabel, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Léonard, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Berlin, Germany
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Fulda, Germany
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Hanover, Germany
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Leipzig, Germany
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Marburg, Germany
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Seto, Aichi-ken, Japan
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Noda, Chiba, Japan
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Touon, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Yukuhashi, Fukuoka, Japan
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Nihommatsu, Fukushima, Japan
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Hiroshima, Hiroshima, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Himeji, Hyōgo, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Ukyo-ku, Kyoto, Kyoto, Japan
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Matsumoto, Nagano, Japan
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Saiki, Oita Prefecture, Japan
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Kishiwada, Osaka, Japan
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Kita-ku, Sakai, Osaka, Japan
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Matsue, Shimane, Japan
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Chūō, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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Tanabe, Wakayama, Japan
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Bunkyō City, Japan
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Iloilo City, Philippines
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Lipa City, Batangas, Philippines
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Quezon City, Philippines
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Bydgoszcz, Poland
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Chęciny, Poland
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Krakow, Poland
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Ostrów Wielkopolski, Poland
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Poznan, Poland
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Proszowice, Poland
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Tczew, Poland
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Wroclaw, Poland
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Zawadzkie, Poland
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Barnaul, Russia, Russia
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Kazan', Russia, Russia
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Moscow, Russia, Russia
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Novosibirsk, Russia, Russia
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Saint Petersburg, Russia, Russia
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Yekaterinburg, Russia, Russia
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Bardejov, Slovakia
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Bojnice, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
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Nové Mesto nad Váhom, Slovakia
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Nové Zámky, Slovakia
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Poprad, Slovakia
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Prešov, Slovakia
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Trnava, Slovakia
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Zvolen, Slovakia
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Žilina, Slovakia
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Wŏnju, Gangwon-do, South Korea
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Uijeongbu-si, Gyeonggi-do, South Korea
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Anyang, South Korea
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Bucheon-si, South Korea
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Daegu, South Korea
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Seoul, South Korea
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Kaohsiung City, Taiwan
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Keelung, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
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Luhansk, Ukraine, Ukraine
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Dnipropetrovsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
Related Publications (3)
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.
PMID: 25287629DERIVEDLeidy 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.
PMID: 24432712DERIVEDVogelmeier 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.
PMID: 22458939DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Claus Volgemeier, Dr.
Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 31, 2009
Study Start
July 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 3, 2012
Results First Posted
August 3, 2012
Record last verified: 2012-06