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

NCT04953741 | Unknown Phase 4 FDA Drug

• 1 other identifier: KY20202053-F-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Fractional exhaled Nitric Oxide, FeNO

  Baseline, 12 weeks and 24 weeks

• Forced expiratory volume in one second in predicted（FEV1%pred）

  Baseline, 12 weeks and 24 weeks

• Forced vital capacity in predicted(FVC%pred)

  Baseline, 12 weeks and 24 weeks

• Maximal mid expiratory flow in predicted(MMEF%pred)

  Baseline, 12 weeks and 24 weeks

• Peak expiratory flow (PEF)

  Baseline, 12 weeks and 24 weeks

Study Arms (3)

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

Drug: Fluticasone propionate inhaled aerosol

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

Drug: Fluticasone propionate inhaled aerosol

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

Drug: Fluticasone propionate inhaled aerosol

Interventions

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.

Stop Fluticasone propionate Inhaled Aerosol Firstly; Stop Montelukast Firstly; Stop Montelukast Secondly

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Pediatrics, Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

Related 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.

  PMID: 29972079 RESULT

Central Study Contacts

Xin Sun, doctor

CONTACT

+8613572536262; sunxin6@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 8, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 8, 2021

Record last verified: 2020-09

Locations

CN (1)