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

NCT04004351 | Completed

• 1 other identifier: PROTECT
• Study Type: observational
• Target: 1,531
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergy

Outcome Measures

Primary Outcomes (3)

• HDM sublingual immunotherapy (SLIT) daily maintenance dose

  Percentage of physicians who prescribed HDM SLIT at the standard dose (%)

  At the inclusion visit

• Total duration of HDM SLIT prescription planned by the physician

  Duration of treatment prescribed (in months)

  At the inclusion visit

• Proportion of physicians who prescribed symptomatic medication with HDM SLIT

  Percentage of physicians (%)

  At the inclusion visit

Secondary Outcomes (10)

• Proportion of patients with symptom relief after HDM SLIT

  At the follow-up visit (between 6 and 12 months after the inclusion visit)

• Overall efficacy of HDM SLIT

  At follow-up visit (between 6 and 12 months after the inclusion visit)

• Proportion of patients with symptomatic medication reduction

  At follow-up visit (between 6 and 12 months after the inclusion visit)

• Proportion of patients with decrease of impact of allergic disease on their every day life

  At the follow-up visit (between 6 and 12 months after the inclusion visit)

• Physicians' overall level of satisfaction with HDM SLIT

  At the follow-up visit (between 6 and 12 months after the inclusion visit)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stallergenes Greer: lead
• Monitoring Force Group: collaborator

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Bertrand Delaisi, MD

  Robert Debré Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: July 2, 2019
• Study Start: September 16, 2013
• Primary Completion: July 12, 2016
• Study Completion: July 12, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07