Individualized Therapy For Asthma in Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.
研究概览
简要总结
The INFANT study will test whether, in preschool children 12-59 months of age with persistent asthma, the following Step 2 asthma therapies will provide similar degrees of asthma control:
- Daily inhaled corticosteroid (ICS) treatment,
- Daily leukotriene receptor antagonist (LTRA) treatment, and
- As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.
详细描述
INFANT is a double-blind, randomized clinical trial in which all participants will receive each of the three therapies for 16 weeks by means of a cross-over study design. INFANT aims to determine whether individual children respond better to one treatment than another and, if so, whether those children can be identified by phenotypic characteristics or selected biomarkers. In this regard the INFANT study is expected to address critical gaps in current asthma management guidelines. Ultimately, the findings from this study are expected to help clarify treatment modalities for this population of young preschool children who are extremely difficult to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-59 months of age.
- •If the child is not currently taking long-term asthma controller therapy (meaning that the child has taken no inhaled corticosteroid or leukotriene receptor antagonist medication whatsoever over the past 6 months), then one of the following criteria must be met:
- •Daytime asthma symptoms more than two days per week (average over the past 4 weeks),
- •At least one nighttime awakening from asthma (over the past 4 weeks),
- •Two or more asthma exacerbations requiring systemic corticosteroids in the previous 6 months,
- •Four or more wheezing episodes in the previous 12 months.
- •If the child is currently taking long-term asthma controller therapy (meaning that the child has taken daily or intermittent/as-needed inhaled corticosteroid or leukotriene receptor antagonist over the past 6 months), then one of the following criteria must be met:
- •Taking inhaled corticosteroid or leukotriene receptor antagonist for more than 3 months (or more than 90 days) out of the previous 6 months (or 180 days),
- •Daytime asthma symptoms more than two days per week (average over the past 4 weeks),
- •More than one nighttime awakening from asthma (over the past 4 weeks),
- •Two or more asthma exacerbations requiring systemic corticosteroids in the previous 12 months,
- •Four or more wheezing episodes in the previous 12 months.
- •Up to date with immunizations, including varicella (unless the subject has already had clinical varicella).
- •Willingness to provide informed consent by the child's parent or guardian.
排除标准
- •Allergic reaction to the study medications or any component of the study drugs, including (but not limited to) urticaria, rash, angioedema, or hypotension following delivery,
- •Chronic medical disorders that could interfere with drug metabolism/excretion (for instance chronic hepatic, biliary, or renal disease),
- •Chronic medical disorders that may increase the risk of drug-related injury, including (but not limited to):
- •Osteogenesis imperfecta (increased risk of bone demineralization/fracture with corticosteroid therapy),
- •Crohn's disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with corticosteroid therapy),
- •G6PD deficiency (increased risk of hemolytic anemia with acetaminophen use),
- •Phenylketonuria (potential for aspartame exposure with study interventions),
- •Seizure disorder treated with anticonvulsants (risk of acetaminophen toxicity with carbamazepine), or
- •History of clotting disorders or Factor deficiency (increased risk of bleeding with corticosteroids),
- •Co-morbid disorders associated with wheezing including (but not limited to) immune deficiency disorders, cystic fibrosis, aspiration, clinically-relevant gastroesophageal reflux, tracheomalacia, congenital airway anomalies (clefts, fistulas, slings, rings), bronchiectasis, bronchopulmonary dysplasia, and/or history of premature birth before 35 weeks gestation,
- •Significant developmental delay/failure to thrive, defined as 5th percentile for height and/or weight or crossing of two major percentile lines during the last year for age and sex,
- •History of a near-fatal asthma exacerbation requiring intubation or assisted ventilation,
- •No primary medical caregiver (e.g., a nurse practitioner, physician assistant, physician, or group medical practice such as a hospital-based clinic) whom the subject can contact for primary medical care,
- •Three or more hospitalizations in the previous 12 months for wheezing or respiratory illnesses,
- •Treatment with 5 or more courses of systemic corticosteroids (oral, intramuscular or intravenous) in the past 6 months,
- •Current use of higher than step 2 NAEPP asthma guideline therapy
- •If receiving allergy shots, change in the dose within the past 3 months.
研究组 & 干预措施
Crossover sequence 1
daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
干预措施: daily fluticasone propionate (Drug)
Crossover sequence 1
daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
干预措施: Montelukast (Drug)
Crossover sequence 1
daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
干预措施: as-needed fluticasone propionate (Drug)
Crossover sequence 2
daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
干预措施: daily fluticasone propionate (Drug)
Crossover sequence 2
daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
干预措施: Montelukast (Drug)
Crossover sequence 2
daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
干预措施: as-needed fluticasone propionate (Drug)
Crossover sequence 3
daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
干预措施: daily fluticasone propionate (Drug)
Crossover sequence 3
daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
干预措施: Montelukast (Drug)
Crossover sequence 3
daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
干预措施: as-needed fluticasone propionate (Drug)
Crossover sequence 4
daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
干预措施: daily fluticasone propionate (Drug)
Crossover sequence 4
daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
干预措施: Montelukast (Drug)
Crossover sequence 4
daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
干预措施: as-needed fluticasone propionate (Drug)
Crossover sequence 5
as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
干预措施: daily fluticasone propionate (Drug)
Crossover sequence 5
as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
干预措施: Montelukast (Drug)
Crossover sequence 5
as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
干预措施: as-needed fluticasone propionate (Drug)
Crossover sequence 6
as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
干预措施: daily fluticasone propionate (Drug)
Crossover sequence 6
as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
干预措施: Montelukast (Drug)
Crossover sequence 6
as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
干预措施: as-needed fluticasone propionate (Drug)
结局指标
主要结局
Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.
时间窗: The last 14 weeks of each 16-week treatment period
The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthcare visits. Children were defined as differential responders if, first, the time to an asthma exacerbation was at least four weeks longer, or second, if the number of annualized ACDs was at least 31 days more for one treatment than another, in that order. If neither threshold was met, the participant was considered a non differential responder. Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.
次要结局
未报告次要终点
研究者
dave mauger
Principal Investigator, AsthmaNet Data Coordinating Center
Milton S. Hershey Medical Center