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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COPD

Intervention / Treatment
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* Drug: QAX028
* Drug: Placebo
* Drug: Tiotropium bromide
* Drug: QAX028
* Drug: QAX028


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>QAX028 high dose | Drug: QAX028<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: 3<br>Tiotropium bromide | Drug: Tiotropium bromide<br> <br> |
| Active Comparator: 4<br>QAX028 medium dose | Drug: QAX028<br> <br> |
| Active Comparator: 5<br>QAX028 low dose | Drug: QAX028<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18μg and to placebo. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD/TIOTROPIUM/QAX028