Status:
TERMINATED
A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This was an exploratory, randomized, subject- and investigator-blind, placebo-controlled, parallel group, proof-of-mechanism study of multiple oral doses of fevipiprant (QAW039) in chronic obstructive...
Detailed Description
This was an exploratory, randomized, subject- and investigator-blind, placebo-controlled, parallel group, proof-of-mechanism study in COPD subjects with eosinophilia, on standard of care therapy. Stan...
Eligibility Criteria
Inclusion
- Acceptable and reproducible spirometry with post-bronchodilator FEV1/FVC \< 0.7 and post-bronchodilator FEV1≥ 30 and ≤ 80% of predicted at the screening and baseline visits (GOLD stage II or III COPD).
- Patients with a physician-diagnosed history of COPD for at least 1 year prior to screening visit, and a documented history of at least one COPD exacerbation within the year prior to screening visit and on a stable therapy regimen for COPD for at least 4 weeks prior to screening visit with inhaled glucocorticoid + one or more long acting bronchodilator.
- Current or ex-smokers who have a smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, or equivalent).
- Circulating eosinophils ≥ 300 cells/µL blood AND sputum eosinophils ≥ 3% of total cell count during screening period.
Exclusion
- Patients with a past or current medical history of asthma.
- 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.
- 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.
- 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.
- 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.
- Patients on any statin therapy with a CK level \> 2 X ULN at screening.
- 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.
- 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
Key Trial Info
Start Date :
May 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03810183
Start Date
May 21 2019
End Date
January 16 2020
Last Update
October 8 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Frankfurt, Germany, 60596
2
Novartis Investigative Site
Hamburg, Germany, 20354
3
Novartis Investigative Site
Hanover, Germany, 30625
4
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom, BD9 6RJ