Predictors of Asthma Exacerbations in Children - Full Text View

Purpose

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.

Condition	Intervention
Asthma	Other: Methacholine challenge testing


Study Type:	Observational
Study Design:	Observational Model: Case-Crossover Time Perspective: Prospective
Official Title:	Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

Number of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP [ Time Frame: 1 year ] [ Designated as safety issue: No ]


Enrollment:	75
Study Start Date:	August 2011
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: Aerosol Provocation System (Cardinal Health GmbH)

Detailed Description:

Preliminary investigations from our own research group showed that lung function parameters (FEV1, the FEV1/FVC ratio and a moderate to severe hyperresponsiveness to methacholine challenge were risk factors of asthma exacerbations (OR 11.3). In the present study, these parameters will be evaluated in prospective design.

One hundred children will be included in the study. Baseline parameters will be collected in a healthy interval (visit 1), then the children will be followed up for 1 year. If the patients fulfill the criteria for an exacerbation the children will present in our department. We expect that 44% of the children have an exacerbation. All children will present at a second visit after one year (visit 2).

Eligibility


Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Outpatients of departement of Pediatric Pulmonology and Allergology.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449435

Locations


Germany
Goethe University Hospital
Frankfurt, Hesse, Germany, 60590

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

More Information

Publications:

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.

Carlsen KH. What distinguishes the asthmatic amongst the infant wheezers? Pediatr Allergy Immunol. 1997;8(10 Suppl):40-5. Review.

Castro-Rodríguez 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.

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.

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.

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.

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. Epub 2005 Aug 18.

Illi S, von Mutius E, Lau S, Niggemann B, Grüber 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. Erratum in: Lancet. 2006 Sep 30;368(9542):1154.

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.

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, Lødrup 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. Review.

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.

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.


Responsible Party:	Johannes Schulze MD, Cosultant Pediatric Allergy and Pulmonolgy, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT01449435 History of Changes
Other Study ID Numbers:	KGU-238/11
Study First Received:	October 7, 2011
Last Updated:	April 24, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:


Asthma children predictors of exacerbation Methacholine challenge Pulmonary function testing

Additional relevant MeSH terms:


Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Methacholine Chloride Autonomic Agents Bronchoconstrictor Agents	Cholinergic Agents Cholinergic Agonists Miotics Molecular Mechanisms of Pharmacological Action Muscarinic Agonists Neurotransmitter Agents Parasympathomimetics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015