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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

Tracking Information
First Submitted Date August 22, 2013
First Posted Date April 15, 2014
Last Update Posted Date December 21, 2017
Actual Study Start Date November 12, 2013
Estimated Primary Completion Date November 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2014)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02114034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 14, 2014)
  • 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).
  • 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
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cohort Analysis of Clinical and Biological Severe Childhood Asthma
Official Title Cohort Analysis of Clinical and Biological Severe Childhood Asthma
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • whole blood
  • serum
  • Bronchoalveolar lavage fluid
  • bronchial brushing and washing specimens
Sampling Method Non-Probability Sample
Study Population Primary Care Clinic
Condition Severe Asthma
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 20, 2017)
362
Original Estimated Enrollment
 (submitted: April 14, 2014)
676
Estimated Study Completion Date November 2032
Estimated Primary Completion Date November 2032   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02114034
Other Study ID Numbers NI12004
N° ID RCB: 2012-A00539-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2017