Safety and Efficacy of QAW039 in Sputum Eosinophilia and Persistent Asthma

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Physician diagnosis of asthma, as per GINA guidelines GINA guidelines and currently prescribed ICS or ICS-LABA therapy.
• Patients who are demonstrated to have reversible airway obstruction, significant FEV1 variability or airway hyperresponsiveness (AHR), or who have shown such responses in previous test(s) within the last five years.
• An ACQ score ≥ 1.5 at randomization or ≥ 1 exacerbations (requiring higher than the patient's normal dose of OCS or IV corticosteroids for ≥ 3 days) in the past 12 months. The definition of exacerbations includes episodes during which the patient self-administered higher doses of OCS as part of a documented self-management plan initiated by the patient's general practitioner or respiratory physician.
• Patients currently on GINA step 2 to step 5 asthma therapies.
• Sputum eosinophil count ≥ 2% at screening.

Exclusion criteria

• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (CRTH2 antagonists).
• History of long QT syndrome or whose QTc interval (Fridericia's) is prolonged >450 msec for males and >470 msec for females at screening or baseline.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• 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 hCG laboratory test (> 5 mIU/mL).
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the study treatment and for 5 days (5 half-lives) after treatment.
• Acute illness other than asthma which, in the investigator's opinion, may compromise the well-being of the patient or study endpoint assessments at the start of the study
• Patients who are considered unsuitable for inclusion by the assessing physician due to serious co-morbidities such as cancer, emphysema or significant bronchiectasis.
• Recent (within 6 weeks of screening) or current lower respiratory tract infection.
• Patients who have been hospitalized or required high-dose (>10mg prednisolone/day) oral corticosteroid (OCS) therapy within 6 weeks of the screening visit.
• Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening.
• Patients who have a clinically significant abnormality on a 12-lead ECG recorded within one month prior to or at screening.
• Patients with a body mass index (BMI) < 17 or > 40 kg/m2.

Other protocol-defined inclusion/exclusion criteria may apply.