EUCTR2011-004966-13-GB进行中（未招募）1 期
A double-blind, placebo-controlled, study examining theeffect of orally administered QAW039 on sputumeosinophil levels and other efficacy outcomes in patientswith sputum eosinophilia and persistent asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
不适用
A double-blind, placebo-controlled, clinical study examining the effect of QAW039 capsules on lung function and Astma control in non-atopic, asthmatic patients with a baseline lung function of 40-80% predicted, inadequately controlled with low dose therapy with inhaled corticosteroidsModerate-to-severe, persistent asthma, inadequately controlledwith ICS therapy.MedDRA version: 18.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2012-003995-38-CZovartis Pharma Services AG530
进行中（未招募）
1 期
A double-blind, placebo-controlled, clinical study examining the effect of QAW039 capsules on lung function and Astma control in non-atopic, asthmatic patients with a baseline lung function of 40-80% predicted, inadequately controlled with low dose therapy with inhaled corticosteroidsEUCTR2012-003995-38-BEovartis Pharma Services AG530
已完成
2 期
To assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose of inhaled corticosteroids (ICS) as background therapy.CTRI/2014/07/004743ovartis Healthcare Private Limited336
已完成
不适用
The effect of interferential therapy on pain with two different electrode placementow back painACTRN12617000505303Prince Sultan Military College of Health Science160
进行中（未招募）
1 期
A double blind, placebo controlled study to evaluate the safety and immunogenicity of escalating doses of 108 CFU, 109 CFU and 1010 CFU of M04NM11 in patients who have chronic Hepatitis B infection. - Not AvailableChronic hepatitis B virus infectionEUCTR2005-005293-70-GBEmergent Product Development UK Ltd45