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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stop Fluticasone propionate Inhaled Aerosol Firstly | Active Comparator | Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day |
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| Stop Montelukast Secondly | Active Comparator | Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day |
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| Stop Montelukast Firstly | Active Comparator | stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate inhaled aerosol | Drug | The study consists of two stages and include three groups. Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day. The scheme of every group is divided into two stages. Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test (ACT) score | Change in participant's Asthma Control Test (ACT) score | Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks |
| Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed | Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed | Baseline (Week 0) to Week 12 |
| Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed | Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed | Baseline (Week 0) to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional exhaled Nitric Oxide, FeNO | Change in participant's Fractional exhaled Nitric Oxide | Baseline, 12 weeks and 24 weeks |
| Forced expiratory volume in one second in predicted（FEV1%pred） | Change in participant's Forced expiratory volume in one second in predicted |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Sun, doctor | Contact | +8613572536262 | sunxin6@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Xijing Hospital | Xi’an | Shanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29972079 | Result | 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. |
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| Baseline, 12 weeks and 24 weeks |
| Forced vital capacity in predicted(FVC%pred) | Change in participant's Forced vital capacity in predicted | Baseline, 12 weeks and 24 weeks |
| Maximal mid expiratory flow in predicted(MMEF%pred) | Change in participant's Maximal mid expiratory flow in predicted | Baseline, 12 weeks and 24 weeks |
| Peak expiratory flow (PEF) | Change in participant's Peak expiratory flow | Baseline, 12 weeks and 24 weeks |