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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Asthma in Children

Treatments: Drug: Fluticasone propionate inhaled aerosol

Study type: Interventional

Funder types: Other

Identifiers

NCT04953741

KY20202053-F-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Stop Fluticasone propionate Inhaled Aerosol Firstly

Active Comparator group

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

Treatment:

Drug: Fluticasone propionate inhaled aerosol

Stop Montelukast Secondly

Active Comparator group

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

Treatment:

Drug: Fluticasone propionate inhaled aerosol

Stop Montelukast Firstly

Active Comparator group

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

Treatment:

Drug: Fluticasone propionate inhaled aerosol