Impact of AIT on Allergic Rhinitis and Asthma

NCT04125888 | Completed FDA Drug

• 1 other identifier: NI-X-04
• Study Type: observational
• Target: 92,048
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergy; Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Asthma medication use

  From pre-index to follow-up year(s), assessed from 2007 and up to 2017

• Change in asthma disease severity

  From pre-index to follow-up year(s), assessed from 2007 and up to 2017

Study Arms (2)

AIT Cohort

Allergic rhinitis patients with and without asthma treated with AIT

Drug: Allergy immunotherapy (AIT)

Control Cohort

Allergic rhinitis patients with and without asthma not treated with AIT

Interventions

Allergy immunotherapy (AIT) DRUG

Immunotherapy for different types of allergies

AIT Cohort

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Allergic rhinitis patients with and without asthma

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

ALK Abelló

Hørsholm, DK-2970, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34901915 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Respiration Disorders

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiratory Tract Diseases

Study Officials

• Mercedes Romano, PharmD, MBA, MSc

  ALK Abelló

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 14, 2019
• Study Start: July 22, 2019
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

DK (1)