A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
NCT ID: NCT01704495
Last Updated: 2016-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1147 participants
INTERVENTIONAL
2012-11-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD5069 5 mg
AZD5069 oral capsules self-administered twice daily
AZD5069
AZD5069 oral capsules self-administered twice daily.
AZD5069 15 mg
AZD5069 oral capsules self-administered twice daily
AZD5069
AZD5069 oral capsules self-administered twice daily.
AZD5069 45 mg
AZD5069 oral capsules self-administered twice daily
AZD5069
AZD5069 oral capsules self-administered twice daily.
Placebo
Placebo oral capsules self-administered twice daily
Placebo
Placebo oral capsules self-administered twice daily.
Interventions
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AZD5069
AZD5069 oral capsules self-administered twice daily.
Placebo
Placebo oral capsules self-administered twice daily.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of asthma for at least 12 months (GINA 2011)
* Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
* Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
* Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)
Exclusion Criteria
* Patients with recurrent, latent, or chronic infections
* Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
* Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
* Current smoker or smoking history of more than 20 pack years
18 Years
150 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bengt Larsson, MEDICAL SCIENCE DIRECTOR
Role: STUDY_DIRECTOR
AZ Mondal R&D, Sweden
Locations
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Research Site
Gotse Delchev, , Bulgaria
Research Site
Kozloduy, , Bulgaria
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Petrich, , Bulgaria
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Pleven, , Bulgaria
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Razgrad, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Vidin, , Bulgaria
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Mount Pearl, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint Romuald, Quebec, Canada
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Brno, , Czechia
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Jindřichův Hradec, , Czechia
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Karlovy Vary, , Czechia
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Kutná Hora, , Czechia
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Mělník, , Czechia
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Prague, , Czechia
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Strakonice, , Czechia
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Tábor, , Czechia
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Berlin, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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München, , Germany
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Aszód, , Hungary
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Baja, , Hungary
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Cegléd, , Hungary
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Gyula, , Hungary
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Komárom, , Hungary
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Makó, , Hungary
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Monor, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Százhalombatta, , Hungary
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Szeged, , Hungary
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Szombathely, , Hungary
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Guadalajara, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Bialystok, , Poland
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Gdansk, , Poland
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Giżycko, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Proszowice, , Poland
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Skierniewice, , Poland
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Tarnów, , Poland
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Wroclaw, , Poland
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Żnin, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Deva, , Romania
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Iași, , Romania
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Izhevsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Vladikavkaz, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Komárno, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Poprad, , Slovakia
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Spišská Nová Ves, , Slovakia
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Šurany, , Slovakia
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Topoľčany, , Slovakia
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Trenčín, , Slovakia
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Zvolen, , Slovakia
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Cape Town, , South Africa
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Durban, , South Africa
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eManzimtoti, , South Africa
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eMkhomazi, , South Africa
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Pretoria, , South Africa
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhzya, , Ukraine
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Zaporozye, , Ukraine
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Birmingham, , United Kingdom
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Dundee, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
Countries
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References
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O'Byrne PM, Metev H, Puu M, Richter K, Keen C, Uddin M, Larsson B, Cullberg M, Nair P. Efficacy and safety of a CXCR2 antagonist, AZD5069, in patients with uncontrolled persistent asthma: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2016 Oct;4(10):797-806. doi: 10.1016/S2213-2600(16)30227-2. Epub 2016 Aug 27.
Other Identifiers
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2012-001869-33
Identifier Type: -
Identifier Source: secondary_id
D3551C00001
Identifier Type: -
Identifier Source: org_study_id
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