Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Bromides; Tiotropium Bromide

Criteria

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.