Impact of AIT on Allergic Rhinitis and Asthma
Impact of AIT on Allergic Rhinitis and Asthma Using Real World Evidence
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Hørsholm, Denmark, DK-2970
- ALK Abello
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
AIT Cohort
Allergic rhinitis patients with and without asthma treated with AIT
|
Immunotherapy for different types of allergies
|
|
Control Cohort
Allergic rhinitis patients with and without asthma not treated with AIT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From pre-index year to follow-up year(s), assessed from 2007 and up to 2017
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From pre-index to follow-up year(s), assessed from 2007 and up to 2017
|
|
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
|
From pre-index to follow-up year(s), assessed from 2007 and up to 2017
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mercedes Romano, PharmD, MBA, MSc, ALK Abello
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI-X-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.