A clinical trial looking at the effect of QAW039 in patients who have persistent asthma and a given type of white blood cells (eosinophils) in the mucus from their lungs
- Conditions
- sputum eosinophilia and moderate-to-severe asthma (GINA 2-5) incompletely controlled on current therapyMedDRA version: 14.0Level: LLTClassification code 10062305Term: Sputum eosinophils increasedSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.0Level: LLTClassification code 10003561Term: Asthma, unspecifiedSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-004966-13-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Written informed consent must be obtained before any assessment is performed
2. Males and females of any race who are over the age of 18 years at the time informed consent is obtained.
3. Physician diagnosis of asthma, as per GINA guidelines and currently prescribed ICS or ICS-LABA therapy.
4. Patients who are demonstrated to have reversible airway obstruction, significant airflow variability or airway hyperresponsiveness (AHR) as defined in full protocol, or who have shown such responses in previous test(s) within the last five years.
5. An ACQ score = 1.5 at randomisation or = 1 exacerbations (as defined in protocol, requiring higher dose than the patient’s normal dose of OCS or IV corticosteroids for = 3 days) in the past 12 months.
6. Patients currently on GINA step 2 to step 5 asthma therapies.
7. Sputum eosinophil count = 2% at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives to the time of enrollment, whichever is longer.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (CRTH2 antagonists).
3. 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.
4. 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.
5. 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).
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception as defined in full protocol during dosing of study treatment and for 5 days (5 half-lives) after treatment.
7. 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.
8. Patients who are considered unsuitable for inclusion by the assessing physician due to serious co-morbidities such as cancer, emphysema or significant bronchiectasis.
9. Recent (within 6 weeks of screening) or current lower respiratory tract infection.
10. Patients who have been hospitalized or required high-dose (>10mg prednisolone/day) oral corticosteroid (OCS) therapy within 6 weeks of the screening visit.
11. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening as defined in full protocol.
12. Patients who have a clinically significant abnormality on a 12-lead ECG recorded within one month prior to or at screening.
13. Patients with a body mass index (BMI) < 17 or > 40 kg/m2.
14. Patients on maintenance immunotherapy who either began their immunotherapy regimen or had a clinically relevant change to their immunotherapy within 1 month prior to granting informed consent.
15. Use of immunosuppressive medication (except inhaled and topical corticosteroids and low dose (=10mg prednisolone/day) oral corticosteroids) within 30 days before randomization into the study.
16. Use of Xolair (omalizumab) within 6 months before randomization into the study.
17. History of alcohol or other substance abuse.
18. A positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or subject’s verbal report.
19. A positive human immunodeficiency virus test or is taking anti-retroviral medications, as determined by medical history and/or subject’s verbal report.
20. Patients on high-dose statin therapy, as defined in protocol.
21. Patients on statin therapy with a CK level >2 X ULN at screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate a statistically significant reduction in sputum eosinophil levels in inadequately controlled, moderate-to-severe asthmatics (GINA 2- 5), with sputum eosinophilia after treatment with QAW039 for 12 weeks compared to placebo.;Secondary Objective: • To demonstrate that QAW039 provides significantly superior control of asthmatic symptoms as measured by the asthma control questionnaire (ACQ) compared to placebo.<br>• To assess safety and tolerability of QAW039 in this moderate-to-severe asthmatic population as compared to placebo.;Primary end point(s): Sputum eosinophils level;Timepoint(s) of evaluation of this end point: 6 Weeks, 12 Weeks (end of active treatment period) and after a 6-week washout on placebo
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Asthma Control Questionnaire (ACQ);Timepoint(s) of evaluation of this end point: 6 Weeks, 12 Weeks (end of active treatment period) and after a 6-week washout on placebo