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OpenTrials
Completed

NCT Number: NCT04125888

Impact of AIT on Allergic Rhinitis and Asthma

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

ALK Abelló

Hørsholm, DK-2970, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allergy immunotherapy (AIT)

Drug

Immunotherapy for different types of allergies

Primary outcomes

  1. Allergic rhinitis medication use

    Time frame: 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 outcomes

  1. Asthma medication use

    Time frame: 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

  2. Change in asthma disease severity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2019
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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