The Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children

NCT01144910 | Withdrawn

• 1 other identifier: KGU-317/09
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of investigator´s clinical trial is to investigate 52 patients aged three to five years with viral-induced asthma and 52 patients aged three to five years with allergic asthma. Over a time-span of 5 years the investigators will explore lung function and bronchial responsiveness. The investigators plan to evaluate long-term clinical history of moderate to severe bronchial hyperresponsiveness in preschool children with asthma. Therefore factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be explored.

Conditions

Intrinsic Asthma; Allergic Asthma; Allergy; Bronchial Hyperresponsiveness

Keywords

asthma; preschool child; bronchial hyperresponsiveness; methacholine challenge test; atopy

Outcome Measures

Primary Outcomes (1)

• Change of severe bronchial hyperresponsiveness over time of five years.

  Bronchial hyperresponsiveness will be defined by the provocation dose (PD) of methacholine causing a 20% drop of FEV1 (PD-20FEV1).

  five years

Secondary Outcomes (4)

• Bronchial responsiveness of parents

  two years

• Impact of atopy

  five years

• eNO

  five years

• Total-IgE

  five years

Study Arms (2)

BHR non-atopy

Patients from the outpatient Department of Allergy, Pneumology and Cystic fibrosis, children's hospital, Goethe-University, Frankfurt, Germany. Over a time-span of 5 years the investigators will explore the lung function and the bronchial hyperresponsiveness. Bronchial methacholine challenges will be performed at baseline and after 1, 3 and 5 years.

Other: methacholine challenge test

BHR atopy

Patients from the outpatient Department of Allergy, Pneumology and Cystic fibrosis, children's hospital, Goethe-University, Frankfurt, Germany. Over a time-span of 5 years the investigators will explore the lung function and the bronchial hyperresponsiveness. Bronchial methacholine challenges will be performed at baseline and after 1, 3 and 5 years.

Other: methacholine challenge test

Interventions

methacholine challenge test OTHER

2 ml of liquid-dissolved methacholine in concentration of 16 mg/ml dosed in 5 steps of 0.01 mg, 0.1 mg, 0.4 mg, 0.8 mg, and 1.6 mg. 2 minutes after each step up an impulse oscillometry (IOS) and spirometry will be performed. the challenge will be stopped in case of a ≥ 20% decrease from baseline in FEV1 (PD20) and 0,2 mg Salbutamol will be given.

Also known as: There are no other names

BHR non-atopy

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

patients from the outpatient Department of Allergology, Pneumology and Cystic fibrosis, children's hospital, Goethe-University, Frankfurt, Germany

You may qualify if:

• informed consent
• age 3 to 6 years
• diagnosis asthma
• pulmonary function: FEV1 (% pred.)≥ 70%
• ability to carry out 2 reproducible flow volume loops
• moderate to severe BHR (PD20 FEV1 ≤ 0,3 mg methacholine)
• more than 4 weeks interval since last infection
• hours washout period of Short Acting Beta Agonist
• week washout period of Ipratropium Bromide
• week washout period of Long Acting Beta Agonist
• weeks washout period of Systemic Corticosteroids
• weeks washout period of Leukotriene Antagonists

You may not qualify if:

• Age \< 3 and \> 6 Years
• Pulmonary function test: FEV1 (% pred.) \< 70%
• Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
• Incapability to perform spirometry
• Current participation in another clinical trial

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Goethe University

Frankfurt am Main, 60590, Germany

Location

Related Publications (14)

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  PMID: 11029352 BACKGROUND

• Frank PI, Morris JA, Hazell ML, Linehan MF, Frank TL. Long term prognosis in preschool children with wheeze: longitudinal postal questionnaire study 1993-2004. BMJ. 2008 Jun 21;336(7658):1423-6. doi: 10.1136/bmj.39568.623750.BE. Epub 2008 Jun 16.

  PMID: 18558639 BACKGROUND

• Matricardi PM, Illi S, Gruber C, Keil T, Nickel R, Wahn U, Lau S. Wheezing in childhood: incidence, longitudinal patterns and factors predicting persistence. Eur Respir J. 2008 Sep;32(3):585-92. doi: 10.1183/09031936.00066307. Epub 2008 May 14.

  PMID: 18480107 BACKGROUND

• Caudri D, Wijga A, A Schipper CM, Hoekstra M, Postma DS, Koppelman GH, Brunekreef B, Smit HA, de Jongste JC. Predicting the long-term prognosis of children with symptoms suggestive of asthma at preschool age. J Allergy Clin Immunol. 2009 Nov;124(5):903-10.e1-7. doi: 10.1016/j.jaci.2009.06.045. Epub 2009 Aug 8.

  PMID: 19665765 BACKGROUND

• Pijnenburg MW, Bakker EM, Hop WC, De Jongste JC. Titrating steroids on exhaled nitric oxide in children with asthma: a randomized controlled trial. Am J Respir Crit Care Med. 2005 Oct 1;172(7):831-6. doi: 10.1164/rccm.200503-458OC. Epub 2005 Jun 23.

  PMID: 15976380 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

• Nuijsink M, Hop WC, Sterk PJ, Duiverman EJ, de Jongste JC. Long-term asthma treatment guided by airway hyperresponsiveness in children: a randomised controlled trial. Eur Respir J. 2007 Sep;30(3):457-66. doi: 10.1183/09031936.00111806. Epub 2007 May 30.

  PMID: 17537770 BACKGROUND

• Beydon N. Pulmonary function testing in young children. Paediatr Respir Rev. 2009 Dec;10(4):208-13. doi: 10.1016/j.prrv.2009.03.001. Epub 2009 Sep 25.

  PMID: 19879511 BACKGROUND

• Beydon N. Assessment of bronchial responsiveness in preschool children. Paediatr Respir Rev. 2006;7 Suppl 1:S23-5. doi: 10.1016/j.prrv.2006.04.016. Epub 2006 Jun 5.

  PMID: 16798575 BACKGROUND

• Holgate ST, Davies DE, Powell RM, Howarth PH, Haitchi HM, Holloway JW. Local genetic and environmental factors in asthma disease pathogenesis: chronicity and persistence mechanisms. Eur Respir J. 2007 Apr;29(4):793-803. doi: 10.1183/09031936.00087506.

  PMID: 17400878 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

• Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.

  PMID: 10619836 BACKGROUND

• Hagmolen of ten Have W, van den Berg NJ, van der Palen J, Bindels PJ, van Aalderen WM. Validation of a single concentration methacholine inhalation provocation test (SCIPT) in children. J Asthma. 2005 Jul-Aug;42(6):419-23. doi: 10.1081/JAS-67934.

  PMID: 16293536 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, sputum

MeSH Terms

Conditions

Hypersensitivity; Bronchial Hyperreactivity; Asthma

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Study Officials

• Johannes Schulze, Dr.

  Goethe University, Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cosultant, Pediadric Allergy, Pulmonology and Cystic fibrosis

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 16, 2010
• Study Start: May 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

DE (1)