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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01068613

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

15.5

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: QAX028 Drug: QAX028 Drug: Tiotropium Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QAX028 high dose	Drug: QAX028 QAX028 60 mcg via inhalation device
Experimental: QAX028 low dose	Drug: QAX028 QAX028 20 mcg via inhalation device
Active Comparator: Tiotropium	Drug: Tiotropium Tiotropium via inhalation device
Placebo Comparator: Placebo	Drug: Placebo Placebo to QAX028 via inhalation device

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium [7 days treatment]
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo [7 days treatment]
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients [7 days treatment]
Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028 [7 days treatment]
Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients [7 days treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research Institute, 1211 W. La Palma Ave	Anaheim	California	United States	CA
2	Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive	Normal	Illinois	United States	IL61761
3	Spartanburg Medical Research, 485 Simuel Road	Spartanburg	South Carolina	United States	SC 29303
4	New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway	Knoxville	Tennessee	United States	TN 37920