Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
NCT ID: NCT01023516
Last Updated: 2012-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
615 participants
INTERVENTIONAL
2009-11-30
2010-08-31
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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1
AZD9668
2 x 30 mg oral tablets bd for 12 weeks
2
Placebo
2 x matched placebo to oral tablet bd for 12 weeks
Interventions
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AZD9668
2 x 30 mg oral tablets bd for 12 weeks
Placebo
2 x matched placebo to oral tablet bd for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* FEV1/FVC \< 70% and FEV1 \>= 30 and \< 80 % of predicted post-bronchodilator
* Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
* At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit
Exclusion Criteria
* Current diagnosis of asthma
* Patients who require long term oxygen therapy
* Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Piotr Kuna, Professor
Role: PRINCIPAL_INVESTIGATOR
Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
Locations
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Research Site
Lovech, , Bulgaria
Research Site
Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Troyan Municipality, , Bulgaria
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Varna, , Bulgaria
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Jihlava, , Czechia
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Jindřichův Hradec, , Czechia
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Kladno, , Czechia
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Krnov, , Czechia
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Nový Jičín, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Rokycany, , Czechia
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Třebíč, , Czechia
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Deszk, , Hungary
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Győr, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Százhalombatta, , Hungary
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Szombathely, , Hungary
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Törökbálint, , Hungary
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Vásárosnamény, , Hungary
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Bialystok, , Poland
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Gdynia, , Poland
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Gorzow Wlkp, , Poland
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Grodzisk Mazowiecki, , Poland
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Jelenia Góra, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Piła, , Poland
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Skierniewice, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Constanța, Constanța County, Romania
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Deva, Hunedoara County, Romania
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Bucharest, Romania, Romania
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Bucharest, , Romania
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Iași, , Romania
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Bardejov, , Slovakia
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Bojnice, , Slovakia
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Bratislava, , Slovakia
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Dunajská Streda, , Slovakia
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Humenné, , Slovakia
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Košice, , Slovakia
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Liptovský Hrádok, , 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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Považská Bystrica, , Slovakia
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Prešov, , Slovakia
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Revúca, , Slovakia
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Spišská Nová Ves, , Slovakia
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Trnava, , Slovakia
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Trstená, , Slovakia
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Žilina, , Slovakia
Countries
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References
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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.
Kuna P, Jenkins M, O'Brien CD, Fahy WA. AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in patients with COPD. Respir Med. 2012 Apr;106(4):531-9. doi: 10.1016/j.rmed.2011.10.020. Epub 2011 Dec 23.
Other Identifiers
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D0520C00020
Identifier Type: -
Identifier Source: org_study_id