Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01054170
Last Updated: 2012-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2010-01-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD9668
AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Placebo
Placebo
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
Interventions
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AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Placebo
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* FEV1/FVC \< 70% and FEV1 \>= 40 and \< =70 % of predicted post-bronchodilator
* Ex-smokers for at least 12 months
Exclusion Criteria
* Current diagnosis of asthma
* Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
50 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Asger Dirksen
Role: PRINCIPAL_INVESTIGATOR
Gentofte Hospital, Department of Lung Medicine
Locations
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Research Site
Kingston, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Hellerup, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Odensec, , Denmark
Research Site
Breda, , Netherlands
Research Site
Nieuwegein, , Netherlands
Research Site
Bucharest, , Romania
Research Site
Kyiv, , Ukraine
Countries
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References
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Nordenmark LH, Taylor R, Jorup C. Feasibility of Computed Tomography in a Multicenter COPD Trial: A Study of the Effect of AZD9668 on Structural Airway Changes. Adv Ther. 2015 Jun;32(6):548-66. doi: 10.1007/s12325-015-0215-3. Epub 2015 Jun 5.
Other Identifiers
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D0520C00014
Identifier Type: -
Identifier Source: org_study_id