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Cohort Analysis of Clinical and Biological Severe Childhood Asthma (COBRAPed)

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ClinicalTrials.gov Identifier: NCT02114034
Recruitment Status : Active, not recruiting
First Posted : April 15, 2014
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The purpose of this prospective study is:

  • to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,
  • to determine the clinical and functional outcomes,
  • to identify the factors associated with severe asthma from childhood to adulthood.

Condition or disease
Severe Asthma

Detailed Description:

Severe asthma involves about 5 % of asthmatic children and is associated with a high impact on hospitalizations, absenteeism and quality of life.

Although our knowledge has progressed in a substantial way during the last ten years, a number of unresolved questions persist in particular as regard to the contributing factors and outcomes from early childhood to adulthood.

After parental agreement the following elements will be collected at inclusion: clinical environmental data, pulmonary function, allergy test data (skin prick tests and specific IgE), blood and serum samples for biobank (DNA / SERUM). In a restricted number of children a more extensive work up will be performed which may include flexible bronchoscopy, bronchial brushing and bronchoalveolar lavage.

The follow-up will be performed every 6 months within the framework of the usual care including collection of clinical data and pulmonary function tests. The allergic status will be done again at 6-7 years, 12 years and 18 years.

In the group of children having non-severe asthma, the follow-up will be annual with collection of clinical data and pulmonary function tests.


Study Type : Observational
Actual Enrollment : 362 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Analysis of Clinical and Biological Severe Childhood Asthma
Actual Study Start Date : November 12, 2013
Estimated Primary Completion Date : November 2032
Estimated Study Completion Date : November 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Non-severe asthma
  • Children Controlled without treatment or with low doses of inhaled corticosteroids (<500 mg / day beclometasone equivalent) asthma
  • and Children with normal EFR
  • and Children who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year
  • and Children not admitted in the previous year for asthma
Severe asthma

Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene (inhaler technique and compliance verified) presents one of the 3 criteria following:

  • Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months
  • exacerbations in the previous year:

    • at least one care unit admission or continued resuscitation
    • at least two hospitalizations for acute severe asthma requiring IV therapy
    • at least 2 courses of oral corticosteroids for exacerbations
  • post BD FEV <80% or UARS post BD> 150% predicted



Primary Outcome Measures :
  1. The identification of risk factors for severe asthma [ Time Frame: 18 years ]
    A prospective follow-up of a cohort of severe pediatric asthma. To improve the identification of risk factors for severe asthma, a group of children with non-severe asthma will also be included


Secondary Outcome Measures :
  1. In the medium and longer term assessment [ Time Frame: 4 years ]
    • Identify the functional and clinical outcome in a longitudinal follow-up to a link with asthma in adults.
    • Identify the factors involved appearing during growth or adulthood (pediatric factors associated with severe asthma profile adult).

  2. A short-term assessment [ Time Frame: 4 years ]
    • Identify the main phenotypes of severe asthma by the cluster analysis
    • Identify the factors involved in severity during childhood

  3. Establish a collection of biological samples (serum bank, DNA Bank, tissue Bank) to search for biomarkers of severity and genetic risk factors for the development of asthma in children. [ Time Frame: 18 years ]

Biospecimen Retention:   Samples With DNA
  • whole blood
  • serum
  • Bronchoalveolar lavage fluid
  • bronchial brushing and washing specimens


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
Criteria

Inclusion Criteria:

Children with severe asthma:

  • Child aged 3 to 12 years
  • Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene or short acting nebulized bronchodilators (inhaler technique and compliance verified) presents one of the criteria following:
  • Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months
  • exacerbations in the previous year:

    • at least one care unit admission or continued resuscitation
    • at least two hospitalizations for acute severe asthma requiring IV therapy
    • at least 2 courses of oral corticosteroids for exacerbations
  • post BD FEV <80% or UARS post BD> 150% predicted
  • Signature of consent or the holder (s) of parental authority
  • Particular case of patients treated with Xolair® : Patients currently receiving Xolair® but who met the severity criteria of asthma, as described above, before the start of treatment with Xolair® are includable.

Children with non-severe asthma:

Inclusion Criteria

  • Child aged 3 to 12 years
  • Controlled without treatment or with low doses of inhaled corticosteroids (<500 mg / day beclometasone equivalent) asthma
  • Child with normal EFR (Child over 4 years)
  • Child who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year
  • Child not admitted in the previous year for asthma.
  • Signature of consent or the holder (s) of parental authority

Exclusion Criteria:

  • Child with bronchopulmonary dysplasia
  • Child with severe sequelae of viral infections
  • Refusal of the child or parents Data collection for research and follow up of patients : tests carried out in the 3 months prior to inclusion are used

Blood sample for DNA extraction and the biobank: for young children, sampling at least 4 to 5 ml on dry tubes for serum and 6 ml at least for DNA. These samples should be stored at room temperature, transported within 48 hours to biological resources (CRB) Necker E,fa,ts Malades.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114034


Locations
France
Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02114034     History of Changes
Other Study ID Numbers: NI12004
N° ID RCB: 2012-A00539-34
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Severe asthma,
child,
outcome,

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases