Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol
NCT ID: NCT01555099
Last Updated: 2013-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
353 participants
INTERVENTIONAL
2012-04-30
2013-04-30
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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AZD5423
New study drug
AZD5423
oral inhaled
Budesonide
Comparator to which the new study drug will be compared
Budesonide
oral inhaled
Placebo
No drug to which both other arms will be compared
Placebo
oral inhaled
Interventions
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AZD5423
oral inhaled
Budesonide
oral inhaled
Placebo
oral inhaled
Eligibility Criteria
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Inclusion Criteria
* Men or women aged ≥ 40 years
* Men or post-menopausal or surgically sterile women. Women will be considered post-menopausal if they have been amenorrheic for at least 12 months, and have a follicle stimulating hormone (FSH) plasma concentration within the postmenopausal range as defined by the laboratory. Male patients should be willing to use barrier contraception, i.e. condom (with spermicide) from the day of dosing until at least 5 weeks after the last dose with the study drug.
* Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
* Current maintenance therapy with LABA and/or LAMA, ICS/LABA or ICS plus LAMA combination
* Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for one year)
* Post-bronchodilator FEV1 ≥40 and ≤ 80% of the predicted normal value
* Post-bronchodilator FEV1/FVC \<0,7
* Reversibility of airway obstruction according to reversibility test performed at visit 2, defined as an increase in FEV1 of ≥10% relative baseline after inhalation of in total 400 μg salbutamol or 1 mg terbutaline sulphate
* Chest radiography (not older than 12 months at Visit 2) not showing any pathological changes that would make the patient unsuitable for inclusion as judged by the Investigator
* Able to read and write and use the electronic devices (eDiary and electronic spirometry)
* Ability to complete an eDiary correctly. Baseline diary data had to be recorded for at least 8 (any 8) of the last 10 days of the run-in period to accept patients for randomized treatment (Randomisation Criteria at Visit 3).
Exclusion Criteria
* Any clinically relevant abnormal findings in clinical chemistry, haematology, urinalysis, physical examination, pulse, blood pressure or ECG at Visit 2, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
* Requirement for long term oxygen therapy
* An exacerbation of COPD, defined as use of oral or parenteral glucocorticosteroids or oral/parenteral antibiotics or hospitalisation related to COPD within 6 weeks of Visit 2
* Participation in or scheduled for an intensive COPD rehabilitation program
* Known or suspected hypersensitivity to study therapy or excipients of the study drug
* History of current alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator
* Plasma donation within one month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening.
* Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 2
* Planned in-patient surgery or hospitalisation during the study
* Previous randomisation of treatment into the present study
* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
40 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
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Łodzi, ul. Kopcińskiego 22, 90-153, Łódź, Poland
Locations
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Research Site
Doganovo, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Brest, , France
Research Site
Marseille, , France
Research Site
Montpellier, , France
Research Site
Nice, , France
Research Site
Pessac, , France
Research Site
Balassagyarmat, , Hungary
Research Site
Budapest, , Hungary
Research Site
Deszk, , Hungary
Research Site
Százhalombatta, , Hungary
Research Site
Foggia, FG, Italy
Research Site
Padua, PD, Italy
Research Site
Verona, VR, Italy
Research Site
Napoli, , Italy
Research Site
Pisa, , Italy
Research Site
Bialystok, , Poland
Research Site
Gorzow Wlkp, , Poland
Research Site
Lodz, , Poland
Research Site
Proszowice, , Poland
Research Site
Tarnów, , Poland
Research Site
Barnaul, Russia, Russia
Research Site
Chelyabinsk, , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Vladikavkaz, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Vráble, Slovakia, Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Humenné, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Spišská Nová Ves, , Slovakia
Research Site
Zvolen, , Slovakia
Research Site
Donetsk, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Poltava, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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2011-005389-39
Identifier Type: -
Identifier Source: secondary_id
D2340C00011
Identifier Type: -
Identifier Source: org_study_id