Clinical trial for step-down therapy in patients with mild to moderate asthma

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800020279

Enrollment

Unknown

Registered

2018-12-22

Start date

2018-12-24

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchial asthma

Interventions

step 3 patients with low-dose-budenide/SABA-therapy:budenide 200µg qd+SABA prn

step 3 patients with low-dose-ICS/LABA-maintainence-therapy:symbicort 80/4.5µg qd+prn

step 3 patients with low-dose-ICS/LABA-on-demand-therapy:symbicort 80/4.5µg prn

step 2 patients with low-dose-ICS/LABA-on-demand-therapy:symbicort 80/4.5µg prn

step 2 patients with SABA-prn-therapy:SABA prn

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 12~ 65 years old, patients with asthma diagnosis for at least 6 months(standards of diagnosis refers to GINA2018); currently under treatment of step 2 or step 3; maintenance of asthma control under current treatment for at least 3 months; patients with no moderate to severe acute exacerbations in the last year; patients having no experience of endotracheal intubation or mechanical ventilation due to asthma in the last 5 years; patients agreement with the clinical trials and with signed informed consent.

Exclusion criteria

Exclusion criteria: Patients combined with chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis and other diseases which affect lung function; having a smoking history of > 10 pack years or current smoking; patients with lethal asthma; having upper respiratory tract infection in the last 4 weeks; use of beta blockers, anticholinergics in the last 4 weeks; patients under pregnancy or lactation, or planning to get pregnant during trials; patients combined with poor-controlled comorbidities which affect asthma control; long-term follow-up indicating poor adherence.

Design outcomes

Primary

Measure	Time frame
Asthma control test;asthma control questionnaire;mini-Asthma related Quality Of Life Questionnaire(miniAQLQ);fractional exhaled nitric oxide (FeNO);lung function;	—

Secondary

Measure	Time frame
induced sputum examination;bronchial provocation test;blood routine examination;	—

Contacts

Public ContactChuntao Liu

West China Hospital, Sichuan University

taosen666@vip.163.com+86 18980601802

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026