Bronchial Dilation Test in Wheezy Infants

Guangzhou Institute of Respiratory Disease90 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Asthma

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

State Key Laboratory of Respiratory Disease;China Clinical Research Center of Respiratory Disease;First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

airway resistance(Raw) performed by body plethysmography before and after bronchial dilation test.

airway resistance(Raw) at rest

Time frame: Change from baseline at 20 mins after inhalation of salbutamol

Secondary Outcomes

airway resistance(Raw) performed by body plethysmography

airway resistance(Raw) measured within 24 hours whenever there is an exacerbation of wheeze.

Time frame: at 24 hours of the exacerbation of wheeze

Data from ClinicalTrials.gov

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