Bronchial Dilation Test in Wheezy Infants

Suspended

• Conditions: Asthma

• Registration Number: NCT03467776
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-02-14
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-15
• Last Update Submitted: 2018-03-15
• Study First Posted: 2018-03-16
• Last Update Posted: 2018-03-16
• Study Start: 2018-07
• Primary Completion: 2019-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
airway resistance(Raw) performed by body plethysmography before and after bronchial dilation test.	Change from baseline at 20 mins after inhalation of salbutamol	airway resistance(Raw) at rest

Secondary Outcome Measures

Name	Time	Method
airway resistance(Raw) performed by body plethysmography	at 24 hours of the exacerbation of wheeze	airway resistance(Raw) measured within 24 hours whenever there is an exacerbation of wheeze.

Trial Locations

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