Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.
- Registration Number
- NCT00568503
- Lead Sponsor
- Novartis
- Brief Summary
This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- Male or female patients aged 40-75 years with diagnosis of mild or moderate COPD
- 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
- Patients who can not comply with the following washout periods for standard
COPD treatments as follows should be excluded:
- Short-acting bronchodilators
- Long-acting bronchodilators
- Inhaled steroids
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 QAX028 QAX028 high dose 2 Placebo Placebo 3 Tiotropium bromide Tiotropium bromide 4 QAX028 QAX028 medium dose 5 QAX028 QAX028 low dose
- Primary Outcome Measures
Name Time Method Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18μg and to placebo. throughout the study
- Secondary Outcome Measures
Name Time Method The forced expiratory volume in 1 second (FEV1)and time profile using a kinetic pharmacodynamic (KPD) model on single doses of QAX028. Pharmacokinetics of inhaled doses of QAX028. throughout the study
Trial Locations
- Locations (1)
Novartis Investigator Site
🇩🇰Birkeroed, Denmark