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Trial record 8 of 30 for:    Dermatophagoides pteronyssinus AND Dermatophagoides farinae

N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France (CARIOCA)

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ClinicalTrials.gov Identifier: NCT03746860
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
ITEC Services
Information provided by (Responsible Party):
ALK-Abelló A/S

Brief Summary:
Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house dust mite allergy over a period of 12 months.

Condition or disease Intervention/treatment
Allergic Rhinitis Due to House Dust Mite Allergic Asthma Due to Dermatophagoides Farinae Allergic Asthma Due to Dermatophagoides Pteronyssinus Drug: Tablet, Dispersible

Detailed Description:

Condition:

  • persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication
  • HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Odactra


Intervention Details:
  • Drug: Tablet, Dispersible
    1 tablet/day with 12 SQ-HDM per lyo-tablet
    Other Names:
    • ACARIZAX 12 SQ-HDM
    • Standardised allergen extract from house dust mite


Primary Outcome Measures :
  1. Safety analysis: Number of patients with at least one Adverse Event [ Time Frame: 1 year ]
    Number of patients with at least one Adverse Events related to ACARIZAX®.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults suffering of HDM allergic rhinitis or HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis.

Patients are only included in the study after the decision for treatment with ACARIZAX® has already been made, and only with the objective of documenting data that reflects the treatment and its safety under 'real life' conditions. Accordingly, only examinations and inquiries conforming to routine practice are conducted and documented.

Criteria

Inclusion Criteria:

  • At the discretion of the investigator, patient who will be prescribed ACARIZAX® in line with the approved Summary of Product Characteristics (SmPC) and who have been informed, after explicit written explanation and willing to participate in the study by signed consent

Exclusion Criteria:

  • Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).

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): NCT03746860


Contacts
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Contact: Antoine CHARTIER, Dr + 33 (0)1 41 02 86 51 Antoine.Chartier@alk.net
Contact: Marie ROCHEREAU 33 (0)1 41 02 86 74 Marie.Rochereau@alk.net

Locations
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France
Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34090
Contact: Pascal Demoly, Pr         
Sub-Investigator: Davide CAIMMI, Dr         
Sub-Investigator: Jean-Luc BOURRAIN, Dr         
Sponsors and Collaborators
ALK-Abelló A/S
ITEC Services
Investigators
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Principal Investigator: Pascal DEMOLY, Pr Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE

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Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT03746860     History of Changes
Other Study ID Numbers: NI-MT-05
ID-RCB:2017-A02668-45 ( Other Identifier: Comité de Protection des Personnes SUD MEDITERRANNEE IV )
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ALK-Abelló A/S:
Allergy
Allergic Rhinitis
Allergic Asthma
House Dust Mite
Immunotherapy

Additional relevant MeSH terms:
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Asthma
Rhinitis
Hypersensitivity
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases