Bronchial Dilation Test in Wheezy Infants

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

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.

Study Overview

• Status: Suspended
• Conditions: Asthma

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • State Key Laboratory of Respiratory Disease;China Clinical Research Center of Respiratory Disease;First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all the subjects will be recurited from the First Affiliated Hospital of Guangzhou Medical University

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
healthy; healthy control, 5 months to 3 years
wheezing with atopy; suspected asthma with wheezing (>3 episodes per year) and atopy
wheezing without atopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Collaborators: Firestone Institute for Respiratory Health
• Investigators: Principal Investigator: jinping Zheng, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: asthma; infants; bronchial dilation test; plethysmography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Pathological Conditions, Anatomical; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Dilatation, Pathologic
• Other Study ID Numbers: GIRD201535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO