Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.
NCT ID: NCT00568503
Last Updated: 2011-04-28
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
PHASE1
29 participants
INTERVENTIONAL
2007-10-31
2008-02-29
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
DOUBLE
Study Groups
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1
QAX028 high dose
QAX028
2
Placebo
Placebo
3
Tiotropium bromide
Tiotropium bromide
4
QAX028 medium dose
QAX028
5
QAX028 low dose
QAX028
Interventions
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QAX028
Placebo
Tiotropium bromide
QAX028
QAX028
Eligibility Criteria
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Inclusion Criteria
* Current or X-smokers with a smoking history of \>10 pack-years.
* Screening ipratropium post-bronchodilation FEV1 at 1 h post-dose will be greater than 50% of the normal predicted FEV1 value.
Exclusion Criteria
COPD treatments as follows should be excluded:
* Short-acting bronchodilators
* Long-acting bronchodilators
* Inhaled steroids
40 Years
75 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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NOVARTIS
Role: PRINCIPAL_INVESTIGATOR
Novartis investigative site
Locations
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Novartis Investigator Site
Birkeroed, , Denmark
Countries
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Other Identifiers
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CQAX028A2102
Identifier Type: -
Identifier Source: org_study_id
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