Predictors of Asthma Exacerbations in Children

NCT01449435 | Completed

• 1 other identifier: KGU-238/11
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether parameters of the pulmonary function tests and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.

Conditions

Asthma

Keywords

Asthma; children; predictors of exacerbation; Methacholine challenge; Pulmonary function testing

Outcome Measures

Primary Outcomes (1)

• Number of exacerbations

  An exacerbations is defined as an increased need of salbutamol (more than two puffs per week or more than five puffs per two weeks). In this case patients will be followed up at our hospital and will start an anti-inflammatory therapy, if it is necessary.

  1 year

Secondary Outcomes (1)

• Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP

  1 year

Interventions

Methacholine challenge testing OTHER

Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg

Also known as: Aerosol Provocation System (Cardinal Health GmbH)

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients of departement of Pediatric Pulmonology and Allergology.

You may qualify if:

• Informed consent
• Age \>3 and \<7 years
• Diagnosis of intermittent asthma
• In the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist Singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist Singulair ®)
• The ability to perform three reproducible spirometries
• Examination in infection-free interval (\> 4 weeks infection-free)
• Minimum distance to the following asthma medications:
• Short-acting beta 2-agonists: 8 hours
• Ipratropium bromide: 24 hours
• Long-acting beta 2-agonists: 24 hours
• steroids: 4 weeks
• leukotriene antagonist: 4 weeks

You may not qualify if:

• Age older than 6 years or younger than 4
• The inability to perform spirometry
• Other chronic diseases or infections (eg. HIV, tuberculosis, malignancy)
• Participation in another study

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (12)

• Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8. doi: 10.1056/NEJM199501193320301.

  PMID: 7800004 BACKGROUND

• Carlsen KH. What distinguishes the asthmatic amongst the infant wheezers? Pediatr Allergy Immunol. 1997;8(10 Suppl):40-5. No abstract available.

  PMID: 9455779 BACKGROUND

• Castro-Rodriguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1403-6. doi: 10.1164/ajrccm.162.4.9912111.

  PMID: 11029352 BACKGROUND

• Kurukulaaratchy RJ, Matthews S, Holgate ST, Arshad SH. Predicting persistent disease among children who wheeze during early life. Eur Respir J. 2003 Nov;22(5):767-71. doi: 10.1183/09031936.03.00005903.

  PMID: 14621083 BACKGROUND

• Kurukulaaratchy RJ, Matthews S, Arshad SH. Relationship between childhood atopy and wheeze: what mediates wheezing in atopic phenotypes? Ann Allergy Asthma Immunol. 2006 Jul;97(1):84-91. doi: 10.1016/S1081-1206(10)61375-0.

  PMID: 16892787 BACKGROUND

• Thumerelle C, Deschildre A, Bouquillon C, Santos C, Sardet A, Scalbert M, Delbecque L, Debray P, Dewilde A, Turck D, Leclerc F. Role of viruses and atypical bacteria in exacerbations of asthma in hospitalized children: a prospective study in the Nord-Pas de Calais region (France). Pediatr Pulmonol. 2003 Feb;35(2):75-82. doi: 10.1002/ppul.10191.

  PMID: 12526066 BACKGROUND

• Morgan WJ, Stern DA, Sherrill DL, Guerra S, Holberg CJ, Guilbert TW, Taussig LM, Wright AL, Martinez FD. Outcome of asthma and wheezing in the first 6 years of life: follow-up through adolescence. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1253-8. doi: 10.1164/rccm.200504-525OC. Epub 2005 Aug 18.

  PMID: 16109980 BACKGROUND

• Illi S, von Mutius E, Lau S, Niggemann B, Gruber C, Wahn U; Multicentre Allergy Study (MAS) group. Perennial allergen sensitisation early in life and chronic asthma in children: a birth cohort study. Lancet. 2006 Aug 26;368(9537):763-70. doi: 10.1016/S0140-6736(06)69286-6.

  PMID: 16935687 BACKGROUND

• Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/03007990903485148.

  PMID: 20001651 BACKGROUND

• Beydon N, Davis SD, Lombardi E, Allen JL, Arets HG, Aurora P, Bisgaard H, Davis GM, Ducharme FM, Eigen H, Gappa M, Gaultier C, Gustafsson PM, Hall GL, Hantos Z, Healy MJ, Jones MH, Klug B, Lodrup Carlsen KC, McKenzie SA, Marchal F, Mayer OH, Merkus PJ, Morris MG, Oostveen E, Pillow JJ, Seddon PC, Silverman M, Sly PD, Stocks J, Tepper RS, Vilozni D, Wilson NM; American Thoracic Society/European Respiratory Society Working Group on Infant and Young Children Pulmonary Function Testing. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. Am J Respir Crit Care Med. 2007 Jun 15;175(12):1304-45. doi: 10.1164/rccm.200605-642ST. No abstract available.

  PMID: 17545458 BACKGROUND

• Christmann M, Erffa Sv, Rosewich M, Rose MA, Schulze J, Zielen S. [The repeatability of forced expiratory manoeuvres in 4- to 6-year-old children with intermittent bronchial asthma in healthy and in exacerbated status]. Pneumologie. 2010 Dec;64(12):745-51. doi: 10.1055/s-0030-1255625. Epub 2010 Aug 23. German.

  PMID: 20734282 BACKGROUND

• Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.

  PMID: 19596563 BACKGROUND

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 Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cosultant Pediatric Allergy and Pulmonolgy

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 10, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

DE (1)