Dose Finding Study for QAW039 in Asthma
Dose Finding Study for QAW039 in Asthma
This study aims to demonstrate a clinically significant improvement in Forced Expiratory
 Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled
 by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active
 comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging,
 multi-centre trial.
Inclusion Criteria:

 -  Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009)
 guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy.

 -  Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value
 of 40% to 80% of individual predicted value.

 -  Patients should be allergic or atopic, as diagnosed historically or prior to entry
 into the study.

 -  Patients who are demonstrated to have reversible airway obstruction or airways
 hyper-reactivity or have shown either of such responses in previous test(s) within the
 last year.

 -  An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization.

 Exclusion Criteria:

 -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
 female after conception and until the termination of gestation, confirmed by a
 positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).

 -  Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart
 failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune
 diseases, other lung diseases including chronic bronchitis, chronic obstructive
 pulmonary diseases or emphysema or other conditions characterized by eosinophilia and
 pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary
 aspergillosis, eosinophilic pneumonia, etc.).

 -  Acute illness other than asthma at the start of the study

 -  History of life-threatening asthma, including a history of significant hypercarbia
 (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of
 asthma.

 -  Patients who have had a respiratory tract infection within 4 weeks of the screening
 visit. Patients who develop a respiratory tract infection between screening and the
 randomization visit must be screen failed, and may be permitted to re-enroll at a
 later date.

 -  Current smokers or ex-smokers who stopped smoking within 6 months prior to screening
 or have a smoking history of ≥ 10 pack years.