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Differences of effectiveness of two treatments in children with cough variant asthma

Differences of effectiveness of two treatments in children aged 6-11 with cough variant asthma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039961
Enrollment
Unknown
Registered
2020-11-15
Start date
2020-11-20
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Cough Variant Asthma

Interventions

Control Group:Budesonide Suspension for Inhalation, 1.0mg, bid*7 days
Budesonide Suspension for Inhalation, 0.5mg, bid*49 days
Treatment Group:Budesonide Suspension for Inhalation, 1.0mg+Levosalbutamol Hydrochloride Nebuliser Solution, 0.63mg, bid*7 days

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1. Outpatients aged 6-11 years old; 2. Diagnosed as CVA according to the "Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2016 )" ; 3. The guardian must sign the informed consent form; the subjects with decision-making ability must also sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to inhaled corticosteroids and bronchial relievers; 2. Other diseases with asthma-like manifestations such as congenital heart disease, gastroesophageal reflux, bronchopulmonary dysplasia, bronchiolitis obliterans, etc.; 3. Glucocorticoids were given orally or intravenously within 14 days; 4. The researcher judges that the patients parents or guardians have problems with expression, understanding, reading and writing; 5. The researcher judges that the subject has other diseases that may interfere with the research results.

Design outcomes

Primary

MeasureTime frame
Compared with the control group, the childhood asthma control test (C-ACT) score in the treatment group 56 days after treatment;

Secondary

MeasureTime frame
Compared with the control group, the pulmonary function(PEF, FEV1, FVC, FEV1/FVC%, FEF25-75%, MEF75%, MEF50%, MEF25%) values of the test group after 56 days of treatment;Compared with the control group, the researcher evaluated the effective disease control rate of the patients in the treatment group after 56 days of treatment;Compared with the control group, the number/proportion of bronchial relievers used in the treatment group during the study period;Compared with the control group, the budesonide exposure of the treatment group during the study period;

Countries

China

Contacts

Public ContactLin Rongjun

The Affiliated Hospital of Qingdao University

linrongjun0312@126.com+86 18661805802

Outcome results

None listed

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