NCT01437735已完成2 期
A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,043
- 试验地点
- 1
- 主要终点
- Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12
研究概览
简要总结
This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy.
- •Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value.
- •Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study.
- •Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year.
- •An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization.
排除标准
- •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 human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
- •Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.).
- •Acute illness other than asthma at the start of the study
- •History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
- •Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.
- •Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.
研究组 & 干预措施
QAW039 po dose 1
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 8
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 2
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 3
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 4
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 5
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 6
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 7
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 9
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 10
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 11
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 12
Experimental
干预措施: QAW039 (Drug)
QAW039 po dose 13
Experimental
干预措施: QAW039 (Drug)
Montelukast po 10 mg
Active Comparator
Comparator leukotriene receptor antagonist (LRTA)
干预措施: Montelukast (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12
时间窗: Baseline and week 12
Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.
次要结局
- Comparison of efficacy of QAW039 with that of active comparator as an add-on therapy to Inhaled Corticosteroids (ICS)(Baseline and week 12)
- Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12(Baseline and week 12)
- Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.(Baseline and week 12)
- Assess the effect of QAW039 on asthma symptoms as measured by asthma control diary.(Baseline and week 12)
- Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.(Baseline, week 2, week 4 and week 8)
- Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.(Baseline, week 2, week 4 and week 8)
- Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment.(Baseline and week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Increased Lung Volume as Controller Therapy for AsthmaAsthmaNCT02953431University of Vermont60
招募中
4 期
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe AsthmaAsthmaNCT04743791Sally E. Wenzel MD30
已完成
4 期
A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer SubjectsHealthyNCT00311519Halozyme Therapeutics50
终止
2 期
Acute Effects of Inhaled Treprostinil in Fontan PatientsCongenital Heart DiseaseNCT02769624Children's Hospital Medical Center, Cincinnati15
终止
2 期
Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic FibrosisCystic FibrosisNCT00073463Targeted Genetics Corporation100