NCT01545726
Completed
Phase 2
A Double-blind, Placebo-controlled Study Examining the Effect of Orally Administered QAW039 on Sputum Eosinophil Levels and Other Efficacy Outcomes in Patients With Sputum Eosinophilia and Persistent Asthma
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Change from baseline in sputum eosinophil percentage at week 12 (baseline measurement is defined as sputum eosinophil percentage at Day1 prior to the first dosing).
Overview
Brief Summary
This study will assess the safety and efficacy of QAW039 when added to current therapy in patients that have sputum eosinophilia and persistent asthma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
QAW039
Experimental
Eligible patients will receive QAW039 po 450 mg daily dose.
Intervention: QAW039 (Drug)
Placebo
Placebo Comparator
Placebo to QAW039 (oral capsules) will be administered to match QAW039 schedule.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in sputum eosinophil percentage at week 12 (baseline measurement is defined as sputum eosinophil percentage at Day1 prior to the first dosing).
Time Frame: Visit 3 (day 1); Visit 5 (day 84)
Sputum induction is performed through the inhalation of hypertonic saline. Sputum is collected and assessed for differential cellular content (absolute numbers and percentages). The primary variable will be summarized by treatment and analyzed using an ANCOVA model with treatment as the fixed effect and the respective baseline value as the covariate.
Secondary Outcomes
- Safety and tolerability of QAW039 in patients with moderate to severe asthma(Visit 2 (day -14); Visit 3 (day 1); Visit 4 (day 42); Visit 5 (day 84); Visit 6 (day 126))
- Change from baseline to week 12 in Asthma Control Questionnaire (ACQ)(Visit 3 (day 1); Visit 5 (day 84))
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.Atopic DermatitisNCT01785602Novartis Pharmaceuticals103
Completed
Phase 2
A Clinical Trial to Test How Well Two Drugs, QAW039 and Montelukast Work Both Individually and Together, to Target Allergic Rhinitis Using an Environmental Exposure ChamberAllergic RhinitisNCT01804400Novartis Pharmaceuticals188
Completed
Phase 2
Efficacy, Safety, and Pharmacokinetics of QAW039Persistent AsthmaNCT01253603Novartis Pharmaceuticals170
Completed
Phase 2
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic PatientsAsthmaNCT01836471Novartis Pharmaceuticals345
Terminated
Phase 2
A Proof-of-concept Study to Examine QUC398 in Participants With Knee OAOsteoarthritis, KneeNCT05462990Novartis Pharmaceuticals101