A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma

Asthma in Children Clinical Trial

Official title:

A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04953741
• Other study ID #: KY20202053-F-1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2020
• Source: Xijing Hospital
• Contact: Xin Sun, doctor
• Phone: +8613572536262
• Email: sunxin6[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Drug:
• Fluticasone propionate inhaled aerosol
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.

Locations

Country	Name	City	State
China	Department of Pediatrics, Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	Fractional exhaled Nitric Oxide, FeNO	Change in participant's Fractional exhaled Nitric Oxide	Baseline, 12 weeks and 24 weeks
Secondary	Forced expiratory volume in one second in predicted(FEV1%pred)	Change in participant's Forced expiratory volume in one second in predicted	Baseline, 12 weeks and 24 weeks
Secondary	Forced vital capacity in predicted(FVC%pred)	Change in participant's Forced vital capacity in predicted	Baseline, 12 weeks and 24 weeks
Secondary	Maximal mid expiratory flow in predicted(MMEF%pred)	Change in participant's Maximal mid expiratory flow in predicted	Baseline, 12 weeks and 24 weeks
Secondary	Peak expiratory flow (PEF)	Change in participant's Peak expiratory flow	Baseline, 12 weeks and 24 weeks