Comparison of Efficacy of Inhaled Formoterol and Budesonide Combination versus Budesonide Monotherapy in Children Aged 6 to 18 years with Bronchial Asthma in Improving Disease Control and Quality of Life: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To compare the proportion of children with asthma showing improved asthma control questionnaire(ACQ) score between the two groups
研究概览
简要总结
Background: Asthma is a common illness in children, requiring multiple inhalers and frequent hospital visits, especially in younger children**.**Many studies in the West have shown the benefits of a single inhaler as controller and reliever in moderate asthma, with no added side effects. There is also a recent interest in using a single inhaler in mild asthma, which is being studied by a multi-centric trial. This study will be a step forward for improving evidence in favour of a single inhaler as rescue and reliever medicine in children with asthma, thereby helping in improving compliance, quality of life and decreasing disease severity.
Aim: To compare the efficacy of inhaled Formoterol/ Budesonide combination (controller + reliever) vs budesonide controller with salbutamol reliever in children (6 to 18 years) with bronchial asthma.
Primary Objective: To compare the proportion of children with asthma showing improved Asthma Control Questionnaire score (ACQ) after 12 weeks and 24 weeks of inhaled formoterol/ budesonide combination (controller + reliever) vs budesonide controller with salbutamol reliever.
**Secondary Objectives:**To compare in both arms-
-
The proportion of children showing improved Pediatric Asthma Quality of Life score (PAQLQ)
-
The proportion of children with improved spirometric parameters
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The improvement in level of control of asthma, number and severity of exacerbations, and time to first exacerbation on treatment
Methodology: This study would be single blinded, parallel design, active controlled, two armed randomized control trial to be carried out over 24 weeks. Computer generated random numbers would help the randomization, to be implemented by Sequentially Numbered Opaque Sealed Envelopes. One arm would receive inhaled Formoterol and Budesonide combination as controller in doses appropriate for age and symptom severity as per GINA guidelines. The other arm would receive inhaled Budesonide as controller, and inhaled Salbutamol as reliever, in age and symptom appropriate doses as per GINA guidelines. Spirometry would be done at 0, 12 and 24 weeks. ACQ scoring and PAQLQ scoring would be done at 0 and 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 6-18 years
- •Bronchial asthma requiring treatment as per GINA guidelines step 1 to 4
- •Ability to perform spirometry in accordance with the standards of the American Thoracic Society.
排除标准
- •Co-existent other chronic pulmonary diseases
- •Chronic renal, gastrointestinal diseases, hepatic or cardiac diseases
- •History of active smoking
- •Patient who took a systemic corticosteroid within the previous 4 weeks
- •Prior PICU admission for asthma.
结局指标
主要结局
To compare the proportion of children with asthma showing improved asthma control questionnaire(ACQ) score between the two groups
时间窗: 12 weeks and 24 weeks
次要结局
- To compare the proportion of children showing improved Pediatric Asthma Quality of life score(PAQLQ) between the two groups(24 weeks)
- To compare the proportion of children with improved spirometric parameters between the two groups(24 weeks)
- To compare the improvement in level of control of asthma, number and severity of exacerbations and(time to first exacerbation on treatment in both groups)
研究者
Khushboo Kamal Taneja
All India Institute of Medical Sciences, Rishikesh