Impact of AIT on Allergic Rhinitis and Asthma

Allergy Clinical Trial

Official title:

Impact of AIT on Allergic Rhinitis and Asthma Using Real World Evidence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125888
• Other study ID #: NI-X-04
• Status: Completed
• Start date: July 22, 2019
• Est. completion date: April 16, 2021

Study information

• Verified date: May 2021
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92048
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria for the AIT cohort:

• At least two index-AIT prescriptions during the first FU-year

• At least one confirmed AR diagnosis during the study period

• Continuous enrollment (no gaps in insurance time-defined by days) for 12 months before the index event (in the pre-index period)

• Continuous enrollment (no gaps in insurance time-defined by days) for at least 12 months after the index event (in the post-index period)

Inclusion Criteria for the Control Cohort:

• For the control groups, the same inclusion criteria will apply, with the exception of inclusion criterion 1, i.e. controls have not received AIT before baseline.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Allergy
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Allergy immunotherapy (AIT)
Immunotherapy for different types of allergies

Locations

Country	Name	City	State
Denmark	ALK Abelló	Hørsholm

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergic rhinitis medication use	Number of patients with an AR prescription and number of prescriptions by drug class	From pre-index year to follow-up year(s), assessed from 2007 and up to 2017
Secondary	Asthma medication use	Number of patients with an asthma prescription and number of prescriptions by drug class	From pre-index to follow-up year(s), assessed from 2007 and up to 2017
Secondary	Change in asthma disease severity	Change in asthma disease severity assessed by asthma diagnoses, asthma medication use and severe asthma exacerbation	From pre-index to follow-up year(s), assessed from 2007 and up to 2017