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Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma (PROTECT)

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.
 
ClinicalTrials.gov Identifier: NCT04004351
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Monitoring Force Group
Information provided by (Responsible Party):
Stallergenes Greer

Brief Summary:

Two-stage, prospective, observational, real-world study of HDM-SLIT-naïve children (aged 5-11) and adolescents (aged 12-17) consulting allergists or other specialist physicians in France for an HDM-induced allergy. Physician- and/or patient-reported data on clinical symptoms, sensitization, patient profiles, symptom burdens, patient-physician dialogue, HDM SLIT regimens, and effectiveness were recorded on inclusion, and then again 6 to 12 months after the prescription of an HDM SLIT solution.

The study's primary objective was to describe treatment modalities in children (aged from 5 to 11) and adolescents (aged from 12 to 17) with suspected HDM-induced AR or allergic asthma consulting an allergist or another specialist physician in France.


Condition or disease
Allergy

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Study Type : Observational
Actual Enrollment : 1531 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Modalités de Prise en chaRge en Pratique quOTidienne d'Allergologie Des Enfants et/ou adolesCents souffranT d'Allergie Aux Acariens / Treatment Modalities in Allergist Daily Practice in Children and/or Adolescents Suffering From HDM Allergy
Actual Study Start Date : September 16, 2013
Actual Primary Completion Date : July 12, 2016
Actual Study Completion Date : July 12, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy




Primary Outcome Measures :
  1. HDM sublingual immunotherapy (SLIT) daily maintenance dose [ Time Frame: At the inclusion visit ]
    Percentage of physicians who prescribed HDM SLIT at the standard dose (%)

  2. Total duration of HDM SLIT prescription planned by the physician [ Time Frame: At the inclusion visit ]
    Duration of treatment prescribed (in months)

  3. Proportion of physicians who prescribed symptomatic medication with HDM SLIT [ Time Frame: At the inclusion visit ]
    Percentage of physicians (%)


Secondary Outcome Measures :
  1. Proportion of patients with symptom relief after HDM SLIT [ Time Frame: At the follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of patients (%)

  2. Overall efficacy of HDM SLIT [ Time Frame: At follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Overall efficacy of HDM SLIT rated by the physician on a Visual Analog Scale (Scale from 0: 'not efficacious at all' to 10: 'very efficacious'). The higher the score, the better the outcome.

  3. Proportion of patients with symptomatic medication reduction [ Time Frame: At follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of patients (%)

  4. Proportion of patients with decrease of impact of allergic disease on their every day life [ Time Frame: At the follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of patients (%)

  5. Physicians' overall level of satisfaction with HDM SLIT [ Time Frame: At the follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of physicians satisfied (%)

  6. Patient's overall level of satisfaction with HDM SLIT [ Time Frame: At the follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of patients satisfied (%)

  7. Proportion of patients continuing their treatment with HDM SLIT after the follow-up visit [ Time Frame: At the follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of patients (%)

  8. Proportion of physicians that estimated that the patients' adherence to HDM SLIT was good [ Time Frame: At the follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of physicians (%)

  9. Proportion of patients experiencing a treatment related adverse event [ Time Frame: At the follow-up visit (between 6 and 12 months after the inclusion visit) ]
    Percentage of patients (%)

  10. Proportion of patients from the cross-sectional analysis which HDM sublingual Immunotherapy (SLIT) solution was prescribed by the physician [ Time Frame: At the inclusion visit ]
    Percentage of patients (%)



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Investigating physicians' population:

The study was proposed to a representative sample of allergists and other specialist physicians.

Patients' population:

Each investigating physician could include in the cross-sectional analysis phase the 8 first HDM-associated allergic patients (children and/or adolescents) who were coming by themselves to the physician's practice, meeting the selection criteria and agreeing to participate in the study.

Patients who started a HDMs sublingual immuntherapy at the end of the inclusion visit were included in the longitudinal phase.

Criteria

Inclusion Criteria for the cross-sectional analysis phase:

  1. Child or adolescent aged from 5 to 17.
  2. Patient suffering from House Dust Mites (HDMs)-associated allergic rhinitis, conjunctivitis and/or asthma.
  3. Sensitization to HDMs as proven by a skin prick test or a serum specific IgE assay.
  4. Patient eligible for HDMs sublingual immunotherapy.
  5. Patient who never received HDMs sublingual allergen immunotherapy.
  6. Patient in-print and orally informed on data recorded about him/her in connection with the study objectives.
  7. Patient and parents (or guardians) agreeing to participate in the study.

Inclusion Criterion for the longitudinal analysis phase:

1. HDMs sublingual immunotherapy prescribed at the end of the inclusion visit.

Exclusion Criteria:

  1. Age under 5 or over 18.
  2. Patient who already received HDMs sublingual allergen immunotherapy.
  3. Patient showing contra-indications to immunotherapy: immune disorder, immunodeficiency, malignancy.
  4. Participation in any clinical study involving an investigational product.

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): NCT04004351


Sponsors and Collaborators
Stallergenes Greer
Monitoring Force Group
Investigators
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Principal Investigator: Bertrand Delaisi, MD Robert Debré Hospital, Paris, France
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Responsible Party: Stallergenes Greer
ClinicalTrials.gov Identifier: NCT04004351    
Other Study ID Numbers: PROTECT
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases