The Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Intrinsic Asthma Allergic Asthma Allergy Bronchial Hyperresponsiveness |
Other: methacholine challenge test |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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. |
- Change of severe bronchial hyperresponsiveness over time of five years. [ Time Frame: five years ] [ Designated as safety issue: No ]Bronchial hyperresponsiveness will be defined by the provocation dose (PD) of methacholine causing a 20% drop of FEV1 (PD-20FEV1).
- Bronchial responsiveness of parents [ Time Frame: two years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Influence of atopy on the time course of bronchial hyperresponsiveness.
- eNO [ Time Frame: five years ] [ Designated as safety issue: No ]Influence of the level of exhaled NO on the time course of BHR.
- Total-IgE [ Time Frame: five years ] [ Designated as safety issue: No ]Influence of the level of total-IgE on the time course of BHR
Biospecimen Retention: Samples With DNA
whole blood, serum, sputum
| Estimated Enrollment: | 104 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
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 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
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 3 Years to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients from the outpatient Department of Allergology, Pneumology and Cystic fibrosis, children's hospital, Goethe-University, Frankfurt, Germany
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
Contacts and Locations| Germany | |
| Goethe University | |
| Frankfurt am Main, Germany, 60590 | |
| Principal Investigator: | Johannes Schulze, Dr. | Goethe University, Frankfurt, Germany |
More Information
Publications:
| Responsible Party: | Johannes Schulze MD, Cosultant, Pediadric Allergy, Pulmonology and Cystic fibrosis, Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT01144910 History of Changes |
| Other Study ID Numbers: | KGU-317/09 |
| Study First Received: | June 1, 2010 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
asthma preschool child bronchial hyperresponsiveness methacholine challenge test atopy |
Additional relevant MeSH terms:
|
Asthma Bronchial Hyperreactivity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Methacholine Chloride Miotics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Parasympathomimetics Bronchoconstrictor Agents Respiratory System Agents Therapeutic Uses Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013