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

NCT03746860 | Completed

• 2 other identifiers: NI-MT-05ID-RCB:2017-A02668-45
• Study Type: observational
• Target: 1,508
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis Due to House Dust Mite; Allergic Asthma Due to Dermatophagoides Farinae; Allergic Asthma Due to Dermatophagoides Pteronyssinus

Keywords

Allergy; Allergic Rhinitis; Allergic Asthma; House Dust Mite; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Safety analysis: Number of patients with at least one Adverse Event

  Number of patients with at least one Adverse Events related to ACARIZAX®.

  1 year

Interventions

Tablet, Dispersible DRUG

1 tablet/day with 12 SQ-HDM per lyo-tablet

Also known as: ACARIZAX 12 SQ-HDM, Standardised allergen extract from house dust mite

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead
• ITEC Services: collaborator

Study Sites (1)

Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic

Interventions

Tablets

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Pascal DEMOLY, Pr

  Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 20, 2018
• Study Start: May 9, 2018
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)