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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568503
• Other study ID #: CQAX028A2102
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2007
• Last updated: April 27, 2011
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QAX028

• Placebo

• Tiotropium bromide

• QAX028

• QAX028

Locations

Country	Name	City	State
Denmark	Novartis Investigator Site	Birkeroed

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18µg and to placebo.		throughout the study
Secondary	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