Clinical trial NCT04125888: Impact of AIT on Allergic Rhinitis and Asthma
Official title: Impact of AIT on Allergic Rhinitis and Asthma Using Real World Evidence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Respiratory Disease
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2019-10-14
Enrollment: 92048
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Allergic rhinitis patients with and without asthma

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.

Eligibility criteria: 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

Primary outcomes:
measure: Allergic rhinitis medication use
timeFrame: From pre-index year to follow-up year(s), assessed from 2007 and up to 2017
Secondary outcomes:
measure: Asthma medication use
timeFrame: From pre-index to follow-up year(s), assessed from 2007 and up to 2017
measure: Change in asthma disease severity
timeFrame: From pre-index to follow-up year(s), assessed from 2007 and up to 2017
Other outcomes:
Locations:
city: Hørsholm
country: Denmark
facility: ALK Abelló
Study officials:
affiliation: ALK Abelló
name: Mercedes Romano, PharmD, MBA, MSc
role: STUDY_DIRECTOR
References:
citation: Fritzsching B, Contoli M, Porsbjerg C, Buchs S, Larsen JR, Elliott L, Rodriguez MR, Freemantle N. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Reg Health Eur. 2021 Nov 30;13:100275. doi: 10.1016/j.lanepe.2021.100275. eCollection 2022 Feb.