Bronchial Dilation Test in Wheezy Infants

NCT03467776 | Suspended DMC

• 1 other identifier: GIRD201535
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

infants; asthma; bronchial dilation test; plethysmography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• airway resistance(Raw) performed by body plethysmography

  at 24 hours of the exacerbation of wheeze

Study Arms (3)

healthy

healthy control, 5 months to 3 years

wheezing with atopy

suspected asthma with wheezing (\>3 episodes per year) and atopy

wheezing without atopy

wheezing without atopy

Eligibility Criteria

• Age: 5 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Firestone Institute for Respiratory Health: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• jinping Zheng

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director,GRID

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 16, 2018
• Study Start: July 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)