This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
QAX028 60 mcg via inhalation device
QAX028 20 mcg via inhalation device
Tiotropium via inhalation device
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
Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium
Time frame: 7 days treatment
Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium
Time frame: 7 days treatment
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo
Time frame: 7 days treatment
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients
Time frame: 7 days treatment
Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028
Time frame: 7 days treatment
Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients
Time frame: 7 days treatment
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Placebo to QAX028 via inhalation device