Clinical trial NCT04953741: A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
Official title: A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma in Children
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a 24-week, randomized, parallel group comparative effectiveness study to evaluate the risk of stepping down therapy for patients with well-controlled asthma treated with combination Inhaled corticosteroids (ICS) and Leukotriene receptor antagonist（LTRA).

Detailed description: Asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months. Leukotriene receptor antagonist（LTRA). For children with mild persistent asthma, ICS twice a day combined with LTRA can be used for treatment, but there is no consensus on how to reduce drugs in patients with asthma that is well controlled (reducing the dose of ICS or stopping montelukast). We propose a 24-week, randomized, parallel group comparative effectiveness study comparing three approaches in patients with asthma well-controlled for at least three months on combination ICS and LTRA: Halve the dose of ICS firstly and then stop ICS with montelukast only, stop montelukast firstly and then halve the dose of ICS, and halve the dose of ICS firstly and then stop montelukast. Our goal is to compare the rate of treatment failure and determine the optimal treatment strategy. Additional goals include assessing risk factors for step-down failure.

Eligibility criteria: Inclusion Criteria:

* age 4-14 years
* patients had mild to moderate persistent asthma. Patients have treated with low-dose inhaled corticosteroids (equivalent to Fluticasone propionate inhaled aerosol 250 ug/ day) combined with Leukotriene receptor antagonist (Montelulast) at least 6 months of and had no symptoms of asthma for nearly 3 months under well asthma control(Asthma Control Test (ACT) score more than or equal to 20).
* patients did not suffer from other acute or chronic diseases that may affect their growth and development

Exclusion Criteria:

* patients with severe persistent asthma or mild persistent asthma failed to be well controlled by low-dose ICS after starting treatment
* suffer from other diseases: Congenital heart disease, chronic infectious disease, protracted diarrhea, congenital airway disease, congenital vascular ring malformation, congenital immune deficiency, tracheal foreign body, bronchial lymph node tuberculosis and gastroesophageal reflux etc.
* patients with poor compliance stop medication or fail to take medication on time.

Primary outcomes:
measure: Asthma Control Test (ACT) score
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
measure: Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
timeFrame: Baseline (Week 0) to Week 12
measure: Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
timeFrame: Baseline (Week 0) to Week 24
Secondary outcomes:
measure: Fractional exhaled Nitric Oxide, FeNO
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Forced expiratory volume in one second in predicted（FEV1%pred）
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Forced vital capacity in predicted(FVC%pred)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Maximal mid expiratory flow in predicted(MMEF%pred)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Peak expiratory flow (PEF)
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Pediatrics, Xijing Hospital
state: Shanxi
Study officials:
References:
citation: Bernstein JA, Mansfield L. Step-up and step-down treatments for optimal asthma control in children and adolescents. J Asthma. 2019 Jul;56(7):758-770. doi: 10.1080/02770903.2018.1490752. Epub 2018 Sep 12.