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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00568503
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arms: 5
• Duration (Months): 4
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: QAX028; Drug: Placebo; Drug: Tiotropium bromide; Drug: QAX028; Drug: QAX028	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 QAX028 high dose	Drug: QAX028
Placebo Comparator: 2 Placebo	Drug: Placebo
Active Comparator: 3 Tiotropium bromide	Drug: Tiotropium bromide
Active Comparator: 4 QAX028 medium dose	Drug: QAX028
Active Comparator: 5 QAX028 low dose	Drug: QAX028

Outcome Measures

Primary Outcome Measures

1. Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18μg and to placebo. [throughout the study]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigator Site	Birkeroed		Denmark

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: NOVARTIS, Novartis investigative site

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00568503
• Other Study ID Numbers: CQAX028A2102
• First Posted: Dec 6, 2007
• Last Update Posted: Apr 28, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: COPD/TIOTROPIUM/QAX028
• Additional relevant MeSH terms: Bromides; Tiotropium Bromide

Study Results

No Results Posted as of Apr 28, 2011