Status:
COMPLETED
Bronchodilator Response in 4-12 Years Chinese Controller Naive Asthmatic Children
Lead Sponsor:
Capital Institute of Pediatrics, China
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
4-12 years
Brief Summary
Objectives: 1. To observe BDR distribution curve for Chinese non-asthmatic and controller-naïve asthmatic children from 4-12 years respectively 2. To compare BDR values between non-asthmatic group an...
Detailed Description
This is a prospective observational non-interventional clinical study. 1. Patient population: 300 non-asthmatic and 300 asthmatic children will be recruited. 1. Non-asthmatic group: healthy childre...
Eligibility Criteria
Inclusion
- Non-asthmatic group: healthy children from 4-12 years will be recruited from the Capital Institute of Pediatrics nearby schools
- Inclusion criteria:
- Willingly attend this investigation
- Chest physical tests are normal
- Exclusion criteria:
- The child had been hospitalized for any severe respiratory condition
- A physician had ever stated that the child had asthma, reactive airway diseases, or the child had taken antiasthma medications for symptoms
- The child was diagnosed with congenital heart disease requiring surgery or medications for management
- There are positive responses concerning other serious chest problems, chest surgery, chronic productive cough, recurrent intractable wheezing, and shortness of breath
- The children can not finish the test that met American Thoracic Society criteria for preschool children in a maximum of 6 attempts and are unable to successfully complete post-bronchodilator (BD) spirometry
- Asthmatic group: 4-12 years old asthmatic children will be recruited from the asthma clinic of the Capital Institute of Pediatrics
- Inclusion criteria:
- Diagnose asthma by specialist of asthma (based on symptoms): criteria for the diagnosis of asthma made by the asthma specialist included a history of recurrent coughing, wheezing, or shortness of breath at rest or with exercise, symptomatic improvement after bronchodilator use, and exclusion of other diagnoses
- Asymptomatic or mild symptomatic with no physical signs of wheeze at the time of testing
- Not receiving controller medication 6 weeks prior to the initial evaluation
- Willing to attend this investigation
- Exclusion criteria:
- Using short β2 agonists within 6 hours
- Using long acting β2 agonists within 24 hours
- Can not finish the test that met American Thoracic Society criteria for preschool children in a maximum of 6 attempts and are unable to successfully complete post-bronchodilator spirometry.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
587 Patients enrolled
Trial Details
Trial ID
NCT01500525
Start Date
December 1 2011
End Date
April 1 2015
Last Update
September 28 2021
Active Locations (1)
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1
Capital Institute of Pediatrics
Beijing, Beijing Municipality, China