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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: QAX028; Drug: Placebo; Drug: Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068613

CQAX028A2201

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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62 participants in 4 patient groups, including a placebo group

QAX028 high dose

Experimental group

Treatment:

Drug: QAX028

Drug: QAX028

QAX028 low dose

Experimental group

Treatment:

Drug: QAX028

Drug: QAX028

Tiotropium

Active Comparator group

Treatment:

Drug: Tiotropium

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo