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AsthmaNCT01449435

Predictors of Asthma Exacerbations in Children

An observational study of Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 6 years
Conditions the study is for
Asthma
What is being tested?
Methacholine challenge testing
How many people
75 participants
Where
1 siteGermany
Study dates
Aug 2011to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Outpatients of departement of Pediatric Pulmonology and Allergology.

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Goethe University Hospital

    Frankfurt am Main, Hesse, 60590

Other trials in Germany

About this study

Official title: Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors

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.

Read the 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).

Conditions
Asthma
Being tested
Methacholine challenge testing
Keywords
Asthma, children, predictors of exacerbation, Methacholine challenge, Pulmonary function testing
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methacholine challenge testingOther

    Also called Aerosol Provocation System (Cardinal Health GmbH)

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01449435
Sponsor's protocol ID
KGU-238/11
Status last verified
Apr 2013
First submitted
7 Oct 2011
Last updated
25 Apr 2013
Results posted
No
Data monitoring committee
No

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. doi: 10.1056/NEJM199501193320301.

    PubMed 7800004

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

    PubMed 9455779

  • 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.

    PubMed 11029352

  • 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.

    PubMed 14621083

  • 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.

    PubMed 16892787

  • 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.

    PubMed 12526066

  • 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.

    PubMed 16109980

  • 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.

    PubMed 16935687

  • 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.

    PubMed 20001651

  • 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.

    PubMed 17545458

  • 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.

    PubMed 20734282

  • 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.

    PubMed 19596563

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01449435, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2013.

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