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

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ClinicalTrials.gov Identifier: NCT03810183
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is an exploratory, randomized, subject- and investigator-blind, placebo-controlled, parallel group, proof-of-mechanism study in approximately 50 COPD patients with eosinophilia.

Condition or disease Intervention/treatment Phase
COPD Drug: QAW039 Drug: Placebo Phase 2

Detailed Description:

The study consists of a screening period during which the subject's phenotype and eligibility for the study will be assessed. All subjects will undergo induction of their sputum to examine the baseline sputum cell counts. Subjects will be required to demonstrate both blood and sputum eosinophilia to be eligible for participation in the study. Eligible subjects will be randomized 3:2 to active (QAW039 orally daily) vs. placebo arms.

Subjects will continue their standard of care COPD and other medications during the entire course of the study.

Subjects will receive multiple doses of fevipiprant for six weeks, with safety, efficacy/pharmacodynamic and pharmacokinetic assessments performed.

Sputum induction will be repeated at the end of the treatment period and at the end of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

This is a subject and investigator-blinded study. Subjects, investigators and all site staff will remain blinded to study treatment throughout the study.

Unblinding a single subject at site for safety reasons (if necessary for subject management) will occur via an emergency system in place at the site.

The identity of the treatments will be concealed by the use of study drugs that are all identical in packaging, labeling, schedule of administration, appearance, and odor.

The sponsor may be unblinded to the study treatment at any time, especially in case of a safety concern.

Primary Purpose: Treatment
Official Title: A Multi-center, Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia
Estimated Study Start Date : May 24, 2019
Estimated Primary Completion Date : July 21, 2020
Estimated Study Completion Date : August 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: QAW039
QAW039 450 mg
Drug: QAW039
QAW039 450 mg

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change in sputum eosinophil % of total cell count [ Time Frame: 6 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. 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).
  4. Circulating eosinophils ≥ 300 cells/µL blood AND sputum eosinophils ≥ 3% of total cell count during screening period.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810183


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03810183     History of Changes
Other Study ID Numbers: CQAW039E12201
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QAW039,
Chronic obstructive pulmonary disease,
COPD, sputum,
eosinophillic,
eosinophilia,
prostaglandin D2 receptor,
DP2,
CRTh2,
fevipiprant

Additional relevant MeSH terms:
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Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs