Impact of AIT on Allergic Rhinitis and Asthma

Completed

• Conditions: Allergy; Respiratory Disease
• Interventions: Drug: Allergy immunotherapy (AIT)

• Registration Number: NCT04125888
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

The study will assess the effectiveness of AIT treatment in real clinical practice in Germany.

Detailed Description

Allergic rhinitis (AR) affects 23-30% of the European population and is associated with a major burden on public health. AR and asthma frequently coexist, and may both be caused by allergen exposure. While the efficacy of AIT, i.e. reduce symptoms and medication use in patients with AR and asthma, has been demonstrated in several randomized clinical trials, little is known about the use and effectiveness of AIT in real world clinical practice.

This study is a retrospective database study that uses real-world data from Germany. The study population consists of AR patients with and without asthma treated with AIT and matched controls not treated with AIT. Information about the patients and treatments will be obtained from the 'BKK German Sickness Fund Database' from 2007 until 2017.

Study Timeline

• Study Start: 2019-07-22
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Primary Completion: 2021-04-16
• Study Completion: 2021-04-16
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92048

Inclusion Criteria

Not provided

Exclusion Criteria

• AIT prescription 12 months before the index event (in the pre-index period) for the AIT treatment group

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AIT Cohort	Allergy immunotherapy (AIT)	Allergic rhinitis patients with and without asthma treated with AIT

Primary Outcome Measures

Name	Time	Method
Allergic rhinitis medication use	From pre-index year to follow-up year(s), assessed from 2007 and up to 2017	Number of patients with an AR prescription and number of prescriptions by drug class

Secondary Outcome Measures

Name	Time	Method
Asthma medication use	From pre-index to follow-up year(s), assessed from 2007 and up to 2017	Number of patients with an asthma prescription and number of prescriptions by drug class
Change in asthma disease severity	From pre-index to follow-up year(s), assessed from 2007 and up to 2017	Change in asthma disease severity assessed by asthma diagnoses, asthma medication use and severe asthma exacerbation

Trial Locations

Locations (1)

ALK Abelló; 🇩🇰 Hørsholm, Denmark