Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Double-blind, Double-dummy, Three Period Incomplete Cross-over Study to Evaluate the Safety and Efficacy of Multiple Daily Doses of QAX028 as Compared to Tiotropium Bromide (Positive Control) and Placebo in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068613
• Other study ID #: CQAX028A2201
• Status: Completed
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD according to GOLD guidelines
• Post-bronchodilator 30%=FEV1<80% of predicted normal and ost-bronchodilator FEV1/FVC <0.7
• Smoking history of at least 10 pack years

Exclusion Criteria:

• Requiring oxygen therapy on a daily basis
• Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
• Lung reduction surgery
• Respiratory tract infection in the 6 weeks prior to screening
• Significant cardiac history
• History of asthma with onset of symptoms prior to age 40 years
• Active use of certain COPD medications, beta blockers Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QAX028
QAX028 60 mcg via inhalation device
• QAX028
QAX028 20 mcg via inhalation device
• Tiotropium
Tiotropium via inhalation device
• Placebo
Placebo to QAX028 via inhalation device

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute, 1211 W. La Palma Ave	Anaheim	California
United States	New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway	Knoxville	Tennessee
United States	Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive	Normal	Illinois
United States	Spartanburg Medical Research, 485 Simuel Road	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium		7 days treatment
Secondary	Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium		7 days treatment
Secondary	Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo		7 days treatment
Secondary	Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients		7 days treatment
Secondary	Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028		7 days treatment
Secondary	Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients		7 days treatment

External Links

•   Results for CQAX028A2201 from the Novartis Clinical Trials website