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Bronchial Dilation Test in Wheezy Infants

G

Guangzhou Institute of Respiratory Disease

Status

Suspended

Conditions

Asthma

Study type

Observational

Funder types

Other

Identifiers

NCT03467776
GIRD201535

Details and patient eligibility

About

The purpose of the study is to establish the methodology of bronchial dilation test by salbutamol MDI with Spacer in wheezy infants with asthma and to evaluate the effects of atopy on the exacerbation of wheeze in wheezy infants.

Full description

After screening,each participant undergo baseline pulmonary function test(Jaeger Master Screen Baby Body, Germany)and post-bronchodilator measurements that performed 10min after 200ug of salbutamol administered using a metered-dose inhaler and a spacer.

The participants undergo baseline lung function test and bronchial dilation tests on the second and third visits with one-month interval,and whenever there is an exacerbation.

Enrollment

90 estimated patients

Sex

All

Ages

5 to 36 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • normal term infants.Recurrent wheezing with or without atopy,none of the subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,or requirement for assisted ventilation in the neonatal periods,all infants were asymptomatic for at least 2 weeks preceding the test.

Exclusion criteria

  • subjects had a history of respiratory illness, congenital heart disease,dysphagia,oxygen saturation≤90% on room air,an active seizure disorder,or upper airway obstruction,;all infants were asymptomatic for at least 2 weeks preceding the test.

Trial design

90 participants in 3 patient groups

healthy
Description:
healthy control, 5 months to 3 years
wheezing with atopy
Description:
suspected asthma with wheezing (\>3 episodes per year) and atopy
wheezing without atopy
Description:
wheezing without atopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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