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N/A N=587

Bronchodilator Response in 4-12 Years Chinese Controller Naive Asthmatic Children

Asthma

Enrolled (actual)
587
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Bronchodilator Response in Asthmatic Children — 9.45; 3.30 percentage of BDR — p=<0.05

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Pediatric · 4+ yrs
Sex
All
Sponsor
Capital Institute of Pediatrics, China
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Bronchodilator Response in Asthmatic Children
9.45; 3.30 <0.05 sig

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 and controller-naïve asthmatic group, and analyze appropriate cut-off point value Background and rationale: According to the guidelines spirometry, including baseline forced expiratory volume in 1 second (FEV1) and the bronchodilator response (BDR) to short acting beta agonists (SABA), should be used in children as objective measures to establish the diagnosis and severity of bronchial asthma. Baseline FEV1 is usually in the normal range (greater than 80% predicted) in children, regardless of asthma severity, so several other objective measures have been suggested for diagnosis in children, including the response to a bronchodilator, which reflects airway reversibility. The current definition for a positive BDR is >12% reversibility. In the study carried out by Galant et al among 51 non-asthmatic children and 346 controller naïve asthmatic children between 4-17 years, the BDR value could achieve 12% in only 30.6% asthmatic children, across all severity. Also, in a study among 142 children between 5-10 years in UK, 9% increase in FEV1 after bronchodilator use was suggested as the cutoff point with good sensitivity and specificity. Difference between the proposed study to be carried out in our hospital and the one in Anhui Province is that we will tentatively calculate a BDR cutoff point by using receiver operating characteristic (ROC curve). And the cutoff point can be used as a reference indicator in asthma diagnosis and long-term management. The current BDR cutoff point of 12% that is not ideal for children can also be reflected in the clinical management. It has been shown that a persistent BDR value, even less than 12%, in asthmatic children suggests poor clinical outcome. In a 4 years study among 1041 asthmatic children in America carried out by Sharma et al, it showed that compared with individuals who had a BDR of 12% and 200ml, individuals who had a BDR of 10% had similar poor clinical outcomes (e.g. more hospital visits, more prednisone bursts, increased nocturnal awakenings, and missing more days of school). Same results were also obtained in Galant et al study among 679 asthmatic children among 5-18 years.

Eligibility Criteria

-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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01500525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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