Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199
NCT ID: NCT00736489
Last Updated: 2014-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2008-08-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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crossover dose 1
AZD3199 120 microgram
AZD3199
Dry powder for inhalation, single dose
crossover dose 2
AZD3199 480 microgram
AZD3199
Dry powder for inhalation, single dose
crossover dose 3
AZD3199 1920 microgram
AZD3199
Dry powder for inhalation, single dose
crossover dose 4
Placebo
Placebo
Dry powder for inhalation, single dose
crossover dose 5
Formoterol 9 microgram
Formoterol
Dry powder for inhalation, single dose
crossover dose 6
Formoterol 36 microgram
Formoterol
Dry powder for inhalation, single dose
Interventions
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AZD3199
Dry powder for inhalation, single dose
Formoterol
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and post-menopausal women above 18 years of age.
* Reversible airway obstruction in response to classical beta2-agonist (salbutamol)
* Non/ex-smokers
Exclusion Criteria
* Any clinically relevant abnormal findings at screening examinations
* Treatment with systemic glucocorticosteroids within the past 30 days
* Inhaled corticosteroid use if dosing is not kept constant
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Prof Leif Bjermer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital in Lund, Sweden
Locations
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Research Site
Hvidovre, , Denmark
Research Site
Gothenburg, , Sweden
Research Site
Luleå, , Sweden
Research Site
Lund, , Sweden
Countries
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References
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Bjermer L, Rosenborg J, Bengtsson T, Lotvall J. Comparison of the bronchodilator and systemic effects of AZD3199, an inhaled ultra-long-acting beta(2)-adrenoceptor agonist, with formoterol in patients with asthma. Ther Adv Respir Dis. 2013 Oct;7(5):264-71. doi: 10.1177/1753465813497527. Epub 2013 Aug 1.
Related Links
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Other Identifiers
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ToBe
Identifier Type: -
Identifier Source: secondary_id
D0570C00007
Identifier Type: -
Identifier Source: org_study_id
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