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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QAX028 high dose<br> | Drug: QAX028<br>* QAX028 60 mcg via inhalation device<br>|
| Experimental: QAX028 low dose<br> | Drug: QAX028<br>* QAX028 20 mcg via inhalation device<br>|
| Active Comparator: Tiotropium<br> | Drug: Tiotropium<br>* Tiotropium via inhalation device<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to QAX028 via inhalation device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Long acting muscarinic antagonist