Chronic obstructive pulmonary disease with eosinophilia MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acceptable and reproducible spirometry with post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the change from baseline in sputum eosinophil levels (% of total count) in COPD patients with eosinophilia after multiple oral doses of fevipiprant when compared to placebo.;Secondary Objective: To assess the safety and tolerability of fevipiprant in COPD patients with eosinophilia.;Primary end point(s): Change from baseline in sputum eosinophil % of total cell count in COPD patients with eosinophilia after multiple oral doses of fevipiprant when compared to placebo;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Physical examination, ECG intervals, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, and urinalysis), adverse events including COPD exacerbations.;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Countries
Austria, Belgium, Germany, Spain, United Kingdom, United States
Contacts
Public ContactMedica Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed