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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: A Prospective, Open Label, Single-center Study of the Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children.

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.

Detailed Summary:

A positive family history with prevalence of atopy, eczema, wheezing are well-known factors predicting asthma. Caudri et al. found more important predictors like perinatal transmission, parental use of inhalative medications and wheezing/dyspnea out of viral infections(5). Measurement of BHR in children was in most studies a second outcome parameter.

Four visits will be performed, baseline and after 1, 3, and 5 years. At visit 1 the investigators will characterize all patients by a ISAAC survey. At each visit in children a methacholine challenge, a skin Prick test, eNO, RAST and total IgE will be performed. At visit 3 and 4 sputum will be induced. In parents only at the first visit a methacholine challenge will be performed. A genetic identification of ADAM33 gene from EDTA blood shall be provided. ADAMs are multidomain proteins with a metalloprotease domain, associated with airway remodelling. Visits should be kept in a time interval without asthma therapy and respiratory infection.

To examine the feasibility of methacholine challenges in preschool children data measured in 2006 will be analysed.


Sponsor: Johann Wolfgang Goethe University Hospital

Current Primary Outcome: Change of severe bronchial hyperresponsiveness over time of five years. [ Time Frame: five years ]

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


Original Primary Outcome: Change of severe bronchial hyperresponsiveness over time of five years. [ Time Frame: five years ]

Current Secondary Outcome:

  • Bronchial responsiveness of parents [ Time Frame: two years ]
    In parents at first visit bronchial hyperresponsiveness will be defined by the provocation dose (PD) of methacholine causing a 20% drop of FEV1 (PD-20FEV1).
  • Impact of atopy [ Time Frame: five years ]
    Influence of atopy on the time course of bronchial hyperresponsiveness.
  • eNO [ Time Frame: five years ]
    Influence of the level of exhaled NO on the time course of BHR.
  • Total-IgE [ Time Frame: five years ]
    Influence of the level of total-IgE on the time course of BHR


Original Secondary Outcome:

  • Bronchial responsiveness of parents [ Time Frame: five years ]
    Genetical influence of parental BHR
  • Impact of atopy [ Time Frame: five years ]
    Children with atopy will keep BHR, and children without atopy will outgrow BHR.
  • Parental atopy [ Time Frame: five years ]
    Impact of parental atopy on atopy of children
  • Clinical history [ Time Frame: five years ]
    Children with severe course of disease will be more hyperreactive
  • eNO [ Time Frame: five years ]
    Correlation of exhaled NO and BHR
  • Total-IgE [ Time Frame: five years ]
    Correlation of total-IgE and BHR


Information By: Johann Wolfgang Goethe University Hospital

Dates:
Date Received: June 1, 2010
Date Started: May 2011
Date Completion: September 2017
Last Updated: March 2, 2017
Last Verified: March 2017