Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01068613
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Diagnosis of COPD according to GOLD guidelines
- 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
- Requiring oxygen therapy on a daily basis
- 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
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - QAX028 low dose QAX028 - QAX028 high dose QAX028 - Tiotropium Tiotropium -
- Primary Outcome Measures
Name Time Method Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium 7 days treatment
- Secondary Outcome Measures
Name Time Method Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo 7 days treatment Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients 7 days treatment Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium 7 days treatment Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028 7 days treatment Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients 7 days treatment
Trial Locations
- Locations (4)
Spartanburg Medical Research, 485 Simuel Road
🇺🇸Spartanburg, South Carolina, United States
Advanced Clinical Research Institute, 1211 W. La Palma Ave
🇺🇸Anaheim, California, United States
New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway
🇺🇸Knoxville, Tennessee, United States
Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
🇺🇸Normal, Illinois, United States