Bronchial Dilation Test in Wheezy Infants

Asthma Clinical Trial

Official title:

Brochial Dilation Test by Salbutamol Metered Dose Inhaler(MDI) With Spacer in Wheezy Infants With Asthma Risk Factors

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03467776
• Other study ID #: GIRD201535
• Status: Suspended
• Phase: N/A
• First received: February 14, 2018
• Last updated: March 15, 2018
• Start date: July 2018
• Est. completion date: December 2019

Study information

• Verified date: March 2018
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Firestone Institute for Respiratory Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	airway resistance(Raw) performed by body plethysmography before and after bronchial dilation test.	airway resistance(Raw) at rest	Change from baseline at 20 mins after inhalation of salbutamol
Secondary	airway resistance(Raw) performed by body plethysmography	airway resistance(Raw) measured within 24 hours whenever there is an exacerbation of wheeze.	at 24 hours of the exacerbation of wheeze