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

Novartis

Status and phase: Completed; Phase 1

Conditions: COPD

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00568503

CQAX028A2102

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 5 patient groups, including a placebo group

1

Active Comparator group

Description:

QAX028 high dose

Treatment:

Drug: QAX028

Drug: QAX028

Drug: QAX028

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

3

Active Comparator group

Description:

Tiotropium bromide

Treatment:

Drug: Tiotropium bromide

4

Active Comparator group

Description:

QAX028 medium dose

Treatment:

Drug: QAX028

Drug: QAX028

Drug: QAX028

5

Active Comparator group

Description:

QAX028 low dose

Treatment:

Drug: QAX028

Drug: QAX028

Drug: QAX028