Back to resultsA Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
Primary Purpose
Asthma in Children
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fluticasone propionate inhaled aerosol
Sponsored by
About this trial
This is an interventional treatment trial for Asthma in Children
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.
Sites / Locations
- Department of Pediatrics, Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Stop Fluticasone propionate Inhaled Aerosol Firstly
Stop Montelukast Secondly
Stop Montelukast Firstly
Arm Description
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
Outcomes
Primary Outcome Measures
Asthma Control Test (ACT) score
Change in participant's Asthma Control Test (ACT) score
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
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
Secondary Outcome Measures
Fractional exhaled Nitric Oxide, FeNO
Change in participant's Fractional exhaled Nitric Oxide
Forced expiratory volume in one second in predicted（FEV1%pred）
Change in participant's Forced expiratory volume in one second in predicted
Forced vital capacity in predicted(FVC%pred)
Change in participant's Forced vital capacity in predicted
Maximal mid expiratory flow in predicted(MMEF%pred)
Change in participant's Maximal mid expiratory flow in predicted
Peak expiratory flow (PEF)
Change in participant's Peak expiratory flow
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04953741
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stop Fluticasone propionate Inhaled Aerosol Firstly
Arm Type
Active Comparator
Arm Description
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
Arm Title
Stop Montelukast Secondly
Arm Type
Active Comparator
Arm Description
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
Arm Title
Stop Montelukast Firstly
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate inhaled aerosol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma Control Test (ACT) score
Description
Change in participant's Asthma Control Test (ACT) score
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Description
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Time Frame
Baseline (Week 0) to Week 12
Title
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Description
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Time Frame
Baseline (Week 0) to Week 24
Secondary Outcome Measure Information:
Title
Fractional exhaled Nitric Oxide, FeNO
Description
Change in participant's Fractional exhaled Nitric Oxide
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Forced expiratory volume in one second in predicted（FEV1%pred）
Description
Change in participant's Forced expiratory volume in one second in predicted
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Forced vital capacity in predicted(FVC%pred)
Description
Change in participant's Forced vital capacity in predicted
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Maximal mid expiratory flow in predicted(MMEF%pred)
Description
Change in participant's Maximal mid expiratory flow in predicted
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Peak expiratory flow (PEF)
Description
Change in participant's Peak expiratory flow
Time Frame
Baseline, 12 weeks and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Sun, doctor
Phone
+8613572536262
Email
sunxin6@fmmu.edu.cn
Facility Information:
Facility Name
Department of Pediatrics, Xijing Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Sun, doctor
Phone
+8613572536262
Email
sunxin6@fmmu.edu.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
29972079
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.
Results Reference
result
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A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
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