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

This study has been withdrawn prior to enrollment.
(Due to few capacities 2011 to 2016 the study was withdrawn.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01144910
First Posted: June 16, 2010
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
June 1, 2010
June 16, 2010
March 3, 2017
May 2011
September 2016   (Final data collection date for primary outcome measure)
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).
Change of severe bronchial hyperresponsiveness over time of five years. [ Time Frame: five years ]
Complete list of historical versions of study NCT01144910 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
The Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children
A Prospective, Open Label, Single-center Study of the Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children.
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, serum, sputum
Non-Probability Sample
patients from the outpatient Department of Allergology, Pneumology and Cystic fibrosis, children's hospital, Goethe-University, Frankfurt, Germany
  • Intrinsic Asthma
  • Allergic Asthma
  • Allergy
  • Bronchial Hyperresponsiveness
  • Other: methacholine challenge test

    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.

    Other Name: There are no other names
  • Other: methacholine challenge test

    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.

    Other Name: There are no other names.
  • 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.
    Intervention: 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.
    Intervention: Other: methacholine challenge test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2017
September 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 8 hours washout period of Short Acting Beta Agonist
  • 1 week washout period of Ipratropium Bromide
  • 1 week washout period of Long Acting Beta Agonist
  • 4 weeks washout period of Systemic Corticosteroids
  • 4 weeks washout period of Leukotriene Antagonists

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
3 Years to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01144910
KGU-317/09
No
Not Provided
Not Provided
Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
Johann Wolfgang Goethe University Hospital
Not Provided
Principal Investigator: Johannes Schulze, Dr. Goethe University, Frankfurt, Germany
Johann Wolfgang Goethe University Hospital
March 2017