Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01068613
Last Updated: 2020-12-19
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
62 participants
INTERVENTIONAL
2010-01-31
2010-08-31
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
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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QAX028 high dose
QAX028
QAX028 60 mcg via inhalation device
QAX028 low dose
QAX028
QAX028 20 mcg via inhalation device
Tiotropium
Tiotropium
Tiotropium via inhalation device
Placebo
Placebo
Placebo to QAX028 via inhalation device
Interventions
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QAX028
QAX028 60 mcg via inhalation device
QAX028
QAX028 20 mcg via inhalation device
Tiotropium
Tiotropium via inhalation device
Placebo
Placebo to QAX028 via inhalation device
Eligibility Criteria
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Inclusion Criteria
* Post-bronchodilator 30%≤FEV1\<80% of predicted normal and ost-bronchodilator FEV1/FVC \<0.7
* Smoking history of at least 10 pack years
Exclusion Criteria
* Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
* Lung reduction surgery
* Respiratory tract infection in the 6 weeks prior to screening
* Significant cardiac history
* History of asthma with onset of symptoms prior to age 40 years
* Active use of certain COPD medications, beta blockers
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Advanced Clinical Research Institute, 1211 W. La Palma Ave
Anaheim, California, United States
Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
Normal, Illinois, United States
Spartanburg Medical Research, 485 Simuel Road
Spartanburg, South Carolina, United States
New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway
Knoxville, Tennessee, United States
Countries
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Related Links
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Results for CQAX028A2201 from the Novartis Clinical Trials website
Other Identifiers
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CQAX028A2201
Identifier Type: -
Identifier Source: org_study_id