NCT00568503

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

A Partially Blinded, Single-dose, Cross-over Proof of Concept Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide (Positive Control) and Placebo in Mild-to-moderate COPD Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	QAX028
DRUG	Placebo
DRUG	Tiotropium bromide
DRUG	QAX028
DRUG	QAX028

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-12-06
• Last updated: 2011-04-28

Locations

1 site across 1 country: Denmark