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

NCT01500525 | Completed Results DMC

• 1 other identifier: MISP 40467
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 1.To observe BDR distribution curve for Chinese non-asthmatic and controller-naïve asthmatic children from 4-12 years respectively
2. 2.To compare BDR values between non-asthmatic group and controller-naïve asthmatic group, and analyze appropriate cut-off point value

Conditions

Asthma

Keywords

asthma; children; accuracy of bronchodilator response

Outcome Measures

Primary Outcomes (1)

• Bronchodilator Response in Asthmatic Children

  1. To observe bronchodilator response(BDR) distribution curve for Chinese non-asthmatic children from 4-12 years, BDR calculated as: (FEV 1 L post-bronchodilator - FEV 1 L pre-bronchodilator)/FEV 1 L pre-bronchodilator × 100%. 2. To observe BDR distribution curve for Chinese controller-naïve asthmatic children from 4-12 years 3. To compare BDR values between non-asthmatic group and controller-naïve asthmatic group, and analyze appropriate cut-off point value

  3 years

Study Arms (2)

asthmatic children

children diagnosed by a specialist as asthmatic patients

non-asthmatic children

children who are healthy and who do not have respiratory syndrom

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

300 asthmatic children and 300 non-asthmatic children will be recruited

You may qualify if:

• Willingly attend this investigation
• Chest physical tests are normal

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Capital Institute of Pediatrics, China: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Capital Institute of Pediatrics

Beijing, Beijing Municipality, China

Location

Related Publications (10)

• Bacharier LB, Strunk RC, Mauger D, White D, Lemanske RF Jr, Sorkness CA. Classifying asthma severity in children: mismatch between symptoms, medication use, and lung function. Am J Respir Crit Care Med. 2004 Aug 15;170(4):426-32. doi: 10.1164/rccm.200308-1178OC. Epub 2004 Jun 1.

  PMID: 15172893 RESULT

• Kumar R, Wang B, Wang X, Chen C, Yang J, Fu L, Xu X. Bronchodilator responses in Chinese children from asthma index families and the general population. J Allergy Clin Immunol. 2006 Jun;117(6):1257-63. doi: 10.1016/j.jaci.2006.02.049.

  PMID: 16750984 RESULT

• Galant SP, Morphew T, Amaro S, Liao O. Value of the bronchodilator response in assessing controller naive asthmatic children. J Pediatr. 2007 Nov;151(5):457-62, 462.e1. doi: 10.1016/j.jpeds.2007.05.004.

  PMID: 17961685 RESULT

• Dundas I, Chan EY, Bridge PD, McKenzie SA. Diagnostic accuracy of bronchodilator responsiveness in wheezy children. Thorax. 2005 Jan;60(1):13-6. doi: 10.1136/thx.2004.029934.

  PMID: 15618576 RESULT

• Sharma S, Litonjua AA, Tantisira KG, Fuhlbrigge AL, Szefler SJ, Strunk RC, Zeiger RS, Murphy AJ, Weiss ST; Childhood Asthma Management Program Research Group. Clinical predictors and outcomes of consistent bronchodilator response in the childhood asthma management program. J Allergy Clin Immunol. 2008 Nov;122(5):921-928.e4. doi: 10.1016/j.jaci.2008.09.004. Epub 2008 Oct 10.

  PMID: 18848350 RESULT

• Galant SP, Morphew T, Newcomb RL, Hioe K, Guijon O, Liao O. The relationship of the bronchodilator response phenotype to poor asthma control in children with normal spirometry. J Pediatr. 2011 Jun;158(6):953-959.e1. doi: 10.1016/j.jpeds.2010.11.029. Epub 2011 Jan 13.

  PMID: 21232757 RESULT

• Naqvi M, Thyne S, Choudhry S, Tsai HJ, Navarro D, Castro RA, Nazario S, Rodriguez-Santana JR, Casal J, Torres A, Chapela R, Watson HG, Meade K, LeNoir M, Avila PC, Rodriguez-Cintron W, Burchard EG. Ethnic-specific differences in bronchodilator responsiveness among African Americans, Puerto Ricans, and Mexicans with asthma. J Asthma. 2007 Oct;44(8):639-48. doi: 10.1080/02770900701554441.

  PMID: 17943575 RESULT

• Eigen H, Bieler H, Grant D, Christoph K, Terrill D, Heilman DK, Ambrosius WT, Tepper RS. Spirometric pulmonary function in healthy preschool children. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):619-23. doi: 10.1164/ajrccm.163.3.2002054.

  PMID: 11254514 RESULT

• Aurora P, Stocks J, Oliver C, Saunders C, Castle R, Chaziparasidis G, Bush A; London Cystic Fibrosis Collaboration. Quality control for spirometry in preschool children with and without lung disease. Am J Respir Crit Care Med. 2004 May 15;169(10):1152-9. doi: 10.1164/rccm.200310-1453OC. Epub 2004 Mar 17.

  PMID: 15028561 RESULT

• American Thoracic Society; European Respiratory Society. ATS/ERS statement: raised volume forced expirations in infants: guidelines for current practice. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1463-71. doi: 10.1164/rccm.200408-1141ST. No abstract available.

  PMID: 16301301 RESULT

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

Results Point of Contact

• Title: Ling Cao，MD,Pulmonologist, Professor
• Organization: Capital Institute of Pediatrics

caoling9919@163.com

86-13910610319

Study Officials

• Ling Cao, MD

  Capital Institute of Pediatrics, China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pulmonary Department, Director of Asthma Center

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 28, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2015
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-09

Locations

CN (1)