The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01205269
Last Updated: 2014-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2010-10-31
2010-12-31
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
TRIPLE
Study Groups
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First 50 mcg, then 200 mcg, then placebo
period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
AZD8683, 50 mcg
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
AZD8683, 200 mcg
Dry powder for inhalation, single dose
First 50 mcg, then placebo, then 200 mcg
period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
AZD8683, 50 mcg
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
AZD8683, 200 mcg
Dry powder for inhalation, single dose
First 200 mcg, then placebo, then 50 mcg
period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
AZD8683, 50 mcg
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
AZD8683, 200 mcg
Dry powder for inhalation, single dose
First 200 mcg, then 50 mcg, then placebo
period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
AZD8683, 50 mcg
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
AZD8683, 200 mcg
Dry powder for inhalation, single dose
First placebo, then 200 mcg, then 50 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
AZD8683, 50 mcg
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
AZD8683, 200 mcg
Dry powder for inhalation, single dose
First placebo, then 50 mcg, then 200 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
AZD8683, 50 mcg
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
AZD8683, 200 mcg
Dry powder for inhalation, single dose
Interventions
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AZD8683, 50 mcg
Dry powder for inhalation, single dose
Placebo
Dry powder for inhalation, single dose
AZD8683, 200 mcg
Dry powder for inhalation, single dose
Eligibility Criteria
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Inclusion Criteria
* Current or ex-smokers
* FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC \< 70%
Exclusion Criteria
* Any clinically relevant abnormal findings at screening examinations
* Family history or presence of glaucoma
* Need of long term oxygen therapy
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, MD Professor
Role: PRINCIPAL_INVESTIGATOR
Poland
Locations
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Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Lodz, , Poland
Research Site
Proszowice, , Poland
Countries
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Other Identifiers
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EudraCT number: 2010-020506-15
Identifier Type: -
Identifier Source: secondary_id
D1883C00004
Identifier Type: -
Identifier Source: org_study_id
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