A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia

Exclusion Criteria

• •1. Patients with a past or current medical history of asthma.
• •2. Patients with a past or current medical history of conditions other than COPD or allergic rhinitis that could result in elevated sputum eosinophils (e.g., asthma, hypereosinophilic syndrome, Churg-Strauss Syndrome). Patients with known parasitic infestation within 6 months prior to screening are also excluded.
• •3. Patients who have had a respiratory tract infection or COPD worsening or systemic steroid use within 4 weeks prior to screening visit or between screening and randomization visits.
• •4. Patients with history of concomitant chronic or severe pulmonary disease (e.g., sarcoidosis, interstitial lung disease, cystic fibrosis, tuberculosis). Exception: patients with concomitant mild or moderate pulmonary hypertension or bronchiectasis are permitted to participate.
• •5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception (also called basic contraception)methods during the study.
• •6. Patients on any statin therapy with a CK level \> 2 X ULN at screening.
• •7. Patients who have a clinically significant laboratory abnormality at the screening visit including (but not limited to):
• •* Total white blood cell count \<2500 cells/uL
• •* AST or ALT \> 2.0 X ULN or total bilirubin \> 1.3 X ULN
• •* Estimated Glomerular Filtration Rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation or Bedside Schwartz equation \<55 mL/minute/1.73 m2.
• •8. Patients with any of the following cardiac related concerns:
• •* A resting QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female) at screening visit
• •* A history of familial long QT syndrome or known family history of Torsades de Pointe
• •* Receiving any medications or other agents known to prolong the QT interval
• •* patients with a history of moderate or severe uncontrolled tachyarrhythmias
• •* History of a clinically significant cardiovascular event within 1 year prior to the screening visit, such as acute myocardial infarction, congestive heart failure, unstable arrhythmia
• •* Patients who, in the judgment of the investigator have a clinically significant ECG abnormality such as (but not limited to) sustained ventricular tachycardia, or clinically significant second or third degree AV block without a pacemaker